MAUDE Adverse Event Report: CORDIS CORPORATION SABER 7MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48007004S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During an endovascular therapy case (evt), a 7mm x 4cm 90 saber percutaneous transluminal angioplasty (pta) balloon catheter was used as a pre-dilation after an unknown guidewire crossed the lesion, however it ruptured at 6atm (atmospheres).It was then replaced with another same sized balloon catheter and a drug coated balloon catheter was used as well and the procedure was completed.There was no reported patient injury.This issue might have been caused due to calcification.The lesion was the superficial femoral artery.The device will not be returned for evaluation as it was already discarded.
Additional Manufacturer Narrative
Complaint conclusion: during an endovascular therapy case (evt), a 7mm x 4cm 90 saber percutaneous transluminal angioplasty (pta) balloon catheter was used as a pre-dilation after an unknown guidewire crossed the lesion; however, it ruptured at six atm (atmospheres).There was no reported patient injury.This issue might have been caused due to calcification.The lesion was the superficial femoral artery.The saber was then replaced with another same sized balloon catheter and a drug coated balloon catheter was used as well and the procedure was completed.The product was not returned for analysis as it was discarded by the facility.A product history record (phr) review of lot 82182529 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 of calcification, as noted by the physician, may have contributed to the reported event.However, with the limited amount of information available and 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 safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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 7MM4CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10079396
• Report Number: 9616099-2020-03710
• Device Sequence Number: 3852314
• Product Code: LIT
• UDI-Device Identifier: 20705032068847
• UDI-Public: 20705032068847
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 11/30/2022
• Device Model Number: 48007004S
• Device Catalogue Number: 48007004S
• Device Lot Number: 82182529
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 05/27/2020
• 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: UNKNOWN GUIDEWIRE.