MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 7/40/80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	357290
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 balloon was selected for treatment of a severely calcified lesion in the iliac artery.The device was placed in the target lesion.During inflation at 5 bar, the balloon lost pressure.After removal, a pinhole was detected.A second passeo-35 with same size but another lot number was used and the same problem occurred.
Additional Manufacturer Narrative
The returned instrument was subjected to a 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 of the returned device revealed a fine jet of water in the medial balloon part when applying a pressure.The microscopic analysis of the balloon surface showed a microscopic leakage with tiny scratches close to the pinhole.It seems likely that the damage of the balloon surface was caused by a hard, sharp-edged 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.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.

• Brand Name: PASSEO-35 7/40/80
• 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: 9631855
• Report Number: 1028232-2020-00403
• Device Sequence Number: 3414349
• Product Code: DQY
• UDI-Device Identifier: 07640119558196
• UDI-Public: 07640119558196
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082933
• 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,Followup
• Report Date (Section B): 01/24/2020

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: 12/31/2022
• Device Model Number: 357290
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10197009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1