MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 6/40/130; PERIPHERAL DILATATION CATHETER

Model Number	357496
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product 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 confirmed that the balloon has been inflated.In the as-returned state, the balloon was fully deflated.Upon inflation a fine jet of water was seen to emerge from the center of the balloon.Microscopic inspection revealed a pinhole in the balloon surface about 14 mm distal to the proximal radiopaque marker.In close vicinity to the pinhole, scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each device is tested for air tightness by means of a pressure test and a helium leak test.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The most probable root cause for the reported event is related to the patients anatomy.
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of the left sfa.The passeo-18 balloon catheter ruptured during inflation before reaching the nominal pressure.This was originally reported on mdr-1028232-2025-00004, but the product information was incorrect.That report is being closed and this one opened in its place.

• Brand Name: PASSEO-18 6/40/130
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 21193215
• Report Number: 1028232-2025-00333
• Device Sequence Number: 3467111
• Product Code: LIT
• UDI-Device Identifier: 07640119559070
• UDI-Public: (01)07640119559070(17)2707
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2025

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 Model Number: 357496
• Device Catalogue Number: 357496
• Device Lot Number: 07240450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown