MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM25CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48005025X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two products involved with the reported event and the associated manufacturer report number is: 9616099-2022-05589.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5mm x 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was unable to cross the distal end of a lesion and, after a normal inflation of the balloon to nominal pressure, the balloon was extremely difficult to deflate.The balloon was eventually deflated on its own and was removed easily from the patient in one piece.Another 5mm x 25cm 150cm saber pta balloon catheter from a different lot was used in place of the initial saber pta balloon catheter; however, during an inflation to nominal pressure, the balloon of the second 5mm x 25cm 150cm saber pta balloon catheter ruptured.The ruptured 5mm x 25cm 150cm saber pta balloon catheter was then removed and a 5mm x 20cm saber pta balloon catheter was used without issue.There was no reported injury to the patient.This was during a procedure to treat a calcified lesion in which a non-cordis.014 guidewire was used and there was no observed damage to this guidewire.Both of the 5mm x 25cm 150cm saber pta balloon catheters were stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the devices from their hoop, removing their protective balloon covers, their stylets, any of their sterile packaging components, and the devices were not kinked or damaged in any way prior to being inserted into the patient.A mixture of 1/3rd contrast and 2/3rd saline was used to prep the balloons.A non-cordis 60cc syringe was used for inflation of the saber pta balloon catheters and was successfully used with other devices during this procedure.The saber pta balloon catheters were never in an acute bend and neither device had kinked during its use.The second 5mm x 25cm 150cm saber pta balloon catheter did not experience any issues tracking towards the lesion and was able to cross the lesion with ease.After the second saber pta had ruptured, the device was able to be removed easily and remained in one piece.Information regarding the patient and possible procedural film was requested but was not provided, and both the devices will be returned for evaluation.
Additional Manufacturer Narrative
This is one of two products involved with the reported event and the associated manufacturer report number is: 9616099-2022-05589 after further review of additional information received the following sections have been updated accordingly: complaint conclusion: as reported, a 5mm x 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was unable to cross the distal end of a lesion and, after a normal inflation of the balloon to nominal pressure, the balloon was extremely difficult to deflate.The balloon was eventually deflated on its own and was removed easily from the patient in one piece.Another 5mm x 25cm 150cm saber pta balloon catheter from a different lot was used in place of the initial saber pta balloon catheter; however, during an inflation to nominal pressure, the balloon of the second 5mm x 25cm 150cm saber pta balloon catheter ruptured.The ruptured 5mm x 25cm 150cm saber pta balloon catheter was then removed and a 5mm x 20cm saber pta balloon catheter was used without issue.There was no reported injury to the patient.This was during a procedure to treat a calcified lesion in which a non-cordis.014 guidewire was used and there was no observed damage to this guidewire.Both 5mm x 25cm 150cm saber pta balloon catheters were stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the devices from their hoop, removing their protective balloon covers, their stylets, any of their sterile packaging components, and the devices were not kinked or damaged in any way prior to being inserted into the patient.A mixture of 1/3rd contrast and 2/3rd saline was used to prep the balloons.A non-cordis 60cc syringe was used for inflation of the saber pta balloon catheters and was successfully used with other devices during this procedure.The saber pta balloon catheters were never in an acute bend and neither device had kinked during its use.The second 5mm x 25cm 150cm saber pta balloon catheter did not experience any issues tracking towards the lesion and was able to cross the lesion with ease.After the second saber pta had ruptured, the device was able to be removed easily and remained in one piece.Information regarding the patient and possible procedural film was requested but was not provided.2022-00182058-2 the product was returned for analysis.Per visual analysis of the unit number two analyzed under this complaint, neither damage, nor anomalies could be observed.Per functional analysis, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the saber unit and positive pressure was applied.The balloon was successfully inflated.No anomalies were found during functional analysis.Neither dimensional analysis, nor microscopic analysis were performed due to no anomalies found on the unit received for evaluation.A product history record (phr) review of lot 82219391 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon deflation difficulty - partial or slow¿ and ¿pta/ptca system failure to cross¿ were not confirmed during device analysis.The exact causes cannot be determined.The device inflated/deflated without any difficulties or extended timeframe.The reported ¿balloon burst at/below rbp¿ was not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined.Both returned devices passed functional analysis without any anomalies noted to the products.Therefore, based on the information available, it is difficult to draw a clinical conclusion between the device and the events reported.It is likely procedural factors and handling of the devices may have contributed to the events reported.According to the safety information of the instructions for use ¿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.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.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.Always verify integrity of the catheter after removal.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ 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: SABER 5MM25CM 150
• Common Device Name: 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: 14192187
• Report Number: 9616099-2022-05590
• Device Sequence Number: 11856861
• Product Code: LIT
• UDI-Device Identifier: 20705032069561
• UDI-Public: (01)20705032069561(17)240331(10)82219391
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 48005025X
• Device Catalogue Number: 48005025X
• Device Lot Number: 82219391
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 06/05/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/24/2022; 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM X 20CM SABER PTA BALLOON CATHETER/48005020X; OMNIPAQUE 300 CONTRAST; V-14 .014 GUIDEWIRE
• Patient Sex: Unknown