MAUDE Adverse Event Report: CORDIS CORPORATION SLALOM PTA .018 HP 40 6X4; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4396040T

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unknown sheath introducer (4f).Quidewire (kyousha).A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 40cm 6mm x 4mm slalom percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured after it was inflated several times due to the inflation was not enough.Therefore, the physician tried to remove the device however, the balloon got stuck on the distal end of the unknown sheath and there was resistance felt and kept retracting the device towards the physician.The shaft of the balloon got separated and the proximal side was part of the balloon that was removed.The distal part of the balloon remains on the unknown guidewire.Therefore, an unknown sheath was inserted to the distal part of the lesion, an unknown guidewire was inserted into the unknown sheath and a pull-though procedure was made for the remained part of the balloon to be taken out with an unknown sheath and unknown 4f angio catheter.The remained separated parts of the balloon were removed from the patient¿s body and there was no effect on the patient after the procedure.There were no problems confirmed before and during the use of the device.This was a shunt pta and vascular access intervention therapy vaivt-ace case.A 4f unknown sheath introducer was used and the slalom balloon catheter was used after a non-cordis guidewire crossed the lesion.The physician wants to make sure that all parts of the device were removed from the patient body.The device will be returned for analysis including the separated distal end.

Manufacturer Narrative

Complaint conclusion: during a shunt percutaneous transluminal angioplasty (pta) and vascular access intervention therapy (vaint-ace) case, a 40cm x 6mm x 4mm slalom thrill pta balloon catheter ruptured after it was inflated several times because the inflation was not enough.The physician attempted to remove the device, but the balloon was stuck on the distal end of an unknown 4f sheath introducer due to resistance.The user kept retracting the device towards the physician and the shaft of the balloon separated.Only the proximal side was the part of the balloon that was removed.The other part (the distal side) was on the guidewire.Therefore, an unknown sheath was inserted to the distal part of the lesion, an unknown guidewire was inserted into the sheath and a pull-though procedure was performed.The remaining balloon part was taken with the sheath and an angio catheter (4f).All separated distal ends were eventually removed from the patient¿s body.After the procedure, there was no effect on the patient.The separated distal end will probably be returned for analysis.There were no problems confirmed before and during use of the device.The balloon was initially used after a guidewire crossed the lesion.The doctor would like to make sure that all parts of the device were removed from the patient body.The product was returned for analysis.One non-sterile slalom pta.018 hp 40 6x4 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated, and it was noted to be separated.Blood residues were observed inside the balloon.No other anomalies were observed.A dimensional analysis was performed to verify the correct od at the proximal balloon seal.The measurement was compared against the specification, and the result was found within specification.Functional analysis was not possible due to the damaged condition of the device as received.Per sem analysis, results revealed that the balloon burst was caused by a rupture on the balloon¿s surface.No anomalies were observed adjacent to the balloon rupture on the inner surface of the balloon.The outer surface presented evidence of scratch marks and bulged/peeled off material adjacent to the rupture.This type of damage is commonly associated with the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and bulged/peeled off material on the balloon outer surface could probably led to the rupture condition found on the received balloon.It appears the balloon material near the rupture was torn with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17768150 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was confirmed through analysis of the returned device.However, the reported ¿body/shaft separated - in-patient¿ was not confirmed as the balloon was received separated not the shaft.The reported ¿balloon withdrawal difficulty - through guide/ sheath¿ could not be confirmed due to the nature of the complaint; however, dimensional analysis of the proximal seal was found within spec.Although unknown, it is likely that vessel characteristics may have contributed to the burst as evidenced by scratch marks and bulged/peeled off material noted on the outer surface during analysis.It is likely the balloon was induced to events that exceeded the material yield strength resulting in the separation after the balloon burst, as the device was attempted to be forcefully removed.According to the instructions for use, which is not intended as a mitigation of risk, ¿balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Caution: fully deflate the balloon by inducing negative pressure with the inflation system whenever the pta catheter is advanced or withdrawn.Do not advance or withdraw the pta catheter within the vasculature unless the catheter is preceded by a guidewire.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Remove the vacuum (do not apply pressure) and withdraw the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath or guiding catheter, check if the balloon is fully deflated.If not, withdraw the catheter and sheath as one unit.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Manufacturer Narrative

Complaint conclusion: during a shunt percutaneous transluminal angioplasty (pta) and vascular access intervention therapy (vaint-ace) case, a 40cm x 6mm x 4mm slalom thrill pta balloon catheter ruptured after it was inflated several times because the inflation was not enough.The physician attempted to remove the device, but the balloon was stuck on the distal end of an unknown 4f sheath introducer due to resistance.The user kept retracting the device towards the physician and the shaft of the balloon separated.Only the proximal side was the part of the balloon that was removed.The other part (the distal side) was on the guidewire.Therefore, an unknown sheath was inserted to the distal part of the lesion, an unknown guidewire was inserted into the sheath and a pull-though procedure was performed.The remaining balloon part was taken with the sheath and an angio catheter (4f).All separated distal ends were eventually removed from the patient¿s body.After the procedure, there was no effect on the patient.The separated distal end will probably be returned for analysis.There were no problems confirmed before and during use of the device.The balloon was initially used after a guidewire crossed the lesion.The doctor would like to make sure that all parts of the device were removed from the patient body.The product was returned for analysis.One non-sterile slalom pta.018 hp 40 6x4 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon was received incomplete.The distal segment of the balloon was missing.The inner lumen has a separated condition without the presence of the distal segment and shows a severe elongation characteristic.Neither the balloon separated segment, nor the inner lumen separated segment were returned for analysis.The marker band that must be located on the distal area of the inner lumen is dislodged and it was not returned for analysis.No other anomalies were observed.A dimensional analysis was performed to verify the correct od at the proximal balloon seal.The measurement was compared against the specification, and the result was found within specification.Functional analysis was not possible due to the damaged condition of the device as received.Per sem analysis, results revealed that the balloon burst was caused by a rupture on the balloon¿s surface.No anomalies were observed adjacent to the balloon rupture on the inner surface of the balloon.The outer surface presented evidence of scratch marks and bulged/peeled off material adjacent to the rupture.This type of damage is commonly associated with the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and bulged/peeled off material on the balloon outer surface could probably led to the rupture condition found on the received balloon.It appears the balloon material near the rupture was torn with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17768150 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was confirmed through analysis of the returned device.However, the reported ¿body/shaft separated - in-patient¿ was not confirmed as the balloon was received separated not the shaft.The reported ¿balloon withdrawal difficulty - through guide/ sheath¿ could not be confirmed due to the nature of the complaint; however, dimensional analysis of the proximal seal was found within spec.Although unknown, it is likely that vessel characteristics may have contributed to the burst as evidenced by scratch marks and bulged/peeled off material noted on the outer surface during analysis.It is likely the balloon was induced to events that exceeded the material yield strength resulting in the separation after the balloon burst, as the device was attempted to be forcefully removed.Further analysis revealed the device contained characteristics of severe elongation which is suggestive that the device exceeded its material yield strength upon removal.According to the instructions for use, which is not intended as a mitigation of risk, ¿balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Caution: fully deflate the balloon by inducing negative pressure with the inflation system whenever the pta catheter is advanced or withdrawn.Do not advance or withdraw the pta catheter within the vasculature unless the catheter is preceded by a guidewire.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Remove the vacuum (do not apply pressure) and withdraw the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath or guiding catheter, check if the balloon is fully deflated.If not, withdraw the catheter and sheath as one unit.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SLALOM PTA .018 HP 40 6X4
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9603670
• MDR Text Key: 176115528
• Report Number: 9616099-2020-03489
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 4396040T
• Device Catalogue Number: 4396040T
• Device Lot Number: 17768150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1