MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51006030L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82221003 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during an inflation of a 6mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter to nominal pressure, the balloon ruptured.As a result, the 6mm x 30cm 155cm saberx was removed and a 6mm x 15cm saberx pta balloon catheter was successfully used without evidence of damage and inflated to nominal pressure to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the superficial femoral artery (sfa) which had moderate calcification and mild tortuosity.The 6mm x 30cm 155cm saberx pta balloon catheter was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.A non-cordis inflation device was used and was used successfully with other devices during this procedure.A non-cordis guidewire was also used for the procedure.There was no resistance or friction experienced while inserting the 6mm x 30cm 155cm saberx balloon catheter into the patient.The device was never in an acute bend during this procedure, and it did not kink during its use.After the balloon rupture, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used for the procedure, and the contrast to saline ratio was requested but was not provided, and the device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, during an inflation of a 6mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter to nominal pressure, the balloon ruptured.As a result, the 6mm x 30cm 155cm saberx was removed and a 6mm x 15cm saberx pta balloon catheter was successfully used without evidence of damage and inflated to nominal pressure to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the superficial femoral artery (sfa) which had moderate calcification and mild tortuosity.The 6mm x 30cm 155cm saberx pta balloon catheter was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.A non-cordis inflation device was used and was used successfully with other devices during this procedure.A non-cordis guidewire was also used for the procedure.There was no resistance or friction experienced while inserting the 6mm x 30cm 155cm saberx balloon catheter into the patient.The device was never in an acute bend during this procedure, and it did not kink during its use.After the balloon rupture, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used for the procedure, and the contrast to saline ratio was requested but was not provided.One product was returned for analysis.A non-sterile saber rx 6mm x 30cm 155 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a clear plastic bag.Per visual analysis, the balloon profile was inspected, and it appears to have been previously inflated.No anomalies in the balloon were noted by the naked eye.Per functional analysis, inflation/deflation testing was performed, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.A leakage was observed in the body shaft area of the unit near to the balloon proximal seal.Per microscopic analysis, the unit was inspected under the vision system at the leakage section and a torn condition on the body shaft was observed near the proximal seal area.Sem analysis revealed the leakage on the body/shaft of the saber presented evidence of a ruptured condition and scratch marks near the damaged area.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft probably led to the damaged condition found on the received device.It seems the body/shaft material near the rupture was torn due to the interaction of the unit with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82221003 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ was not confirmed during functional analysis as no anomalies were noted to the balloon material.However, subsequent findings of ¿body/shaft leakage¿ was confirmed via device analysis.The exact cause could not be determined.Device analysis revealed the body/shaft was torn and a leakage was noted from the torn area upon functional analysis.The outer surface of the shaft presented evidence of scratch marks near the torn area.Based on the information provided it appears the body/shaft leakage was caused by the interaction of the shaft material with a sharp object.It is likely vessel characteristics of moderate calcification may have contributed to the reported event as calcification can damage the body/shaft material.According to the instructions for use, which are not intended to mitigate risk, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ 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.

Event Description

As reported, during an inflation of a 6mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter to nominal pressure, the balloon ruptured.As a result, the 6mm x 30cm 155cm saberx was removed and a 6mm x 15cm saberx pta balloon catheter was successfully used without evidence of damage and inflated to nominal pressure to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the superficial femoral artery (sfa) which had moderate calcification and mild tortuosity.The 6mm x 30cm 155cm saberx pta balloon catheter was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.A non-cordis inflation device was used and was used successfully with other devices during this procedure.A non-cordis guidewire was also used for the procedure.There was no resistance or friction experienced while inserting the 6mm x 30cm 155cm saberx balloon catheter into the patient.The device was never in an acute bend during this procedure, and it did not kink during its use.After the balloon rupture, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used for the procedure, and the contrast to saline ratio was requested but was not provided, and the device will be returned for evaluation.Addendum: product evaluation on 08-jun-2022 reveled a leakage of the body/shaft of the 6mm x 30cm 155cm saberx pta balloon catheter.

Manufacturer Narrative

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.

• Brand Name: SABER RX6MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14159197
• MDR Text Key: 293568870
• Report Number: 9616099-2022-05558
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075326
• UDI-Public: (01)20705032075326(17)240430(10)82221003
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51006030L
• Device Lot Number: 82221003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: -6MM X 15CM SABERX PTA BALLOON CATHETER.-14INCH G; 14INCH GLADIUS MG ES, ASAHI INTECC.; GOODMAN INFLATION DEVICE.