MAUDE Adverse Event Report: CORDIS CASHEL SABER 2MM2CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48002002S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A saber (2mm x 2cm x 90cm) percutaneous transluminal angioplasty (pta) balloon catheter was inserted for inflation.However, it ruptured at six atmospheres (6atm).There was no reported patient injury.The saber pta balloon was replaced with a new different size saber pta balloon catheter and the procedure was completed.The target lesion was the superficial femoral artery (sfa).The device was prepped normally per the instructions for use (ifu).The same indeflator was used successfully with other devices.The balloon inflated normally and no unusual force was used at any time during the procedure.There was no device fracture, separation or migration inside the patient body.The device was removed intact (in one piece) from the patient.The product was not returned for analysis.A product history record (phr) review of lot 17621619 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics may have contributed to the reported event, likely calcium as calcification is known to damage balloon material.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the warnings in the safety information in 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.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.
Event or Problem Description
As reported, a saber pta (2mm2cm 90) balloon catheter was inserted for inflation.However, it ruptured at 6-atmospheres pressure (atm).There was no reported patient injury.Therefore, the saber pta balloon was replaced with a new different size saber pta balloon catheter and it could be inflated and the procedure was completed.The target lesion was the superficial femoral artery (sfa).The device was prepped per the instructions for use (ifu).The device was prep normally.The same indeflator was used successfully with other devices.The balloon inflated normally.There was no unusual force used at any time during the procedure.There was no part of the device that fractured nor separated inside the patient body.No part of the device migrated inside the patient body.The device was removed intact (in one piece) from the patient.There is no procedural film/cd available for review.The device will not be returned for evaluation as the device was discarded due to patient¿s infectious disease.

• Brand Name: SABER 2MM2CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• MDR Report Key: 9071364
• Report Number: 9616099-2019-03206
• Device Sequence Number: 19458597
• Product Code: LIT
• UDI-Device Identifier: 20705032069769
• UDI-Public: 20705032069769
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 10/31/2019
• Device Catalogue Number: 48002002S
• Device Lot Number: 17621619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SABER PTA BALLOON CATHETER