MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 3/200/130; PERIPHERAL DILATATION CATHETER

Model Number	376298
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a moderately calcified lesion (55 percent stenosis degree) in a moderately tortuous part of the mid sfa.After delivering the device to the lesion, the balloon could not be inflated.The device was withdrawn and was found broken.
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 revealed that the balloon has been inflated and is thus not well folded anymore.The balloon has burst longitudinally over a length of about 37 mm, starting about 3 mm proximal to the proximal radiopaque.Microscopic inspection of the balloon surface revealed scratches in close vicinity of the tear 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 patient's anatomy.

• Brand Name: PASSEO-18 3/200/130
• 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: 21243147
• Report Number: 1028232-2025-00432
• Device Sequence Number: 3580414
• Product Code: LIT
• UDI-Device Identifier: 07640130430051
• UDI-Public: (01)07640130430051(17)2609
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K151744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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 Expiration Date: 09/10/2026
• Device Model Number: 376298
• Device Catalogue Number: 376298
• Device Lot Number: 08230710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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
• Patient Sex: Unknown