MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 6/60/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	357315
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 balloon catheter was selected to treat a calcified lesion in the medial sfa.During inflation the balloon ruptured.
Additional Manufacturer Narrative
The returned instrument was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the balloon has burst longitudinal over a length of about 47 mm.Microscopic inspection of the balloon showed several deep scratches in close vicinity of the tear.It seems likely that the tear in the balloon was caused by a hard, sharpedged object pressing against the balloon from the outside.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no material or manufacturing related root cause was determined.The root cause is most likely related to the patients anatomy.

• Brand Name: PASSEO-35 6/60/130
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9082637
• Report Number: 1028232-2019-04083
• Device Sequence Number: 2802668
• Product Code: DQY
• UDI-Device Identifier: 07640119558448
• UDI-Public: 07640119558448
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: 06/30/2022
• Device Model Number: 357315
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06191732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1