MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48003015X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 3mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was ruptured.Therefore, it failed to be expanded.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the balloon of a 3mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was ruptured.Therefore, it failed to be expanded.There was no reported patient injury.No other information is provided.The device was not returned for evaluation.A product history record (phr) review of lot 82198069 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown and procedural factors likely contributed to the reported event.However, with the limited amount of information available regarding lesion characteristics 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 3MM15CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 11802505
• Report Number: 9616099-2021-04530
• Device Sequence Number: 19823943
• Product Code: LIT
• UDI-Device Identifier: 20705032069103
• UDI-Public: 20705032069103
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 07/31/2023
• Device Model Number: 48003015X
• Device Catalogue Number: 48003015X
• Device Lot Number: 82198069
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1