MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 7/40/90; PERIPHERAL DILATATION CATHETER

Model Number	357464
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen for treatment.During removal of the protection cap resistance was felt but it could be finally taken off.After insertion of the device it was not possible to inflate the balloon.
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 29 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, 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.The instrument was delivered in a leak-proof condition.Based on the conducted investigations no manufacturing related root cause could be determined.

• Brand Name: PASSEO-18 7/40/90
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9780849
• Report Number: 1028232-2020-01063
• Device Sequence Number: 688511
• Product Code: LIT
• UDI-Device Identifier: 07640119558752
• UDI-Public: 07640119558752
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 04/30/2022
• Device Model Number: 357464
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04195063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1