MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 6/40/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428863
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 xeo peripheral dilatation catheter was selected for treatment of a mildly calcified lesion (90 percent stenosis degree) in a moderately tortuous part of the mid sfa.The balloon was delivered to the lesion but could not pass the lesion.The device was withdrawn and the delivery shaft was found kinked.
Additional Manufacturer Narrative
The returned product 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 this event.The technical investigation revealed that the device shaft is kinked about 16 mm proximal to the distal x-ray marker.A 0.035 inch reference guidewire was introduced into the device from distal and the kink in the balloon section could be passed, but with slightly increased friction.Functional testing was successfully performed by inflating the balloon up to 9 atm (np) and 16 atm (rbp).Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process controls as well as the final inspection during which the outside shaft of all devices is inspected for kinks and a 100 percent control of the lumen viability is performed.During insertion into the protection ring each device is once again controlled for kinks and damages.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: PASSEO-35 XEO 6/40/130
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 21692848
• Report Number: 1028232-2025-01493
• Device Sequence Number: 13069919
• Product Code: LIT
• UDI-Device Identifier: 07640130452343
• UDI-Public: (01)07640130452343(17)2705
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K222065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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
• Device Model Number: 428863
• Device Catalogue Number: 428863
• Device Lot Number: 04244474
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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
• Patient Sex: Unknown