MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2.5/150/130; PERIPHERAL DILATATION CATHETER

Model Number	366130
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a severely calcified lesion (80 percent stenosis degree) in the severely tortuous mid part of the sfa.After dilatation, the device could not be withdrawn over the v18 guide wire.The entire system was removed, and another device was used to finish the procedure.
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 this event.Only the distal device portion (i.E.Balloon and a part of the device shaft) was returned with the guidewire used in the intervention being stuck in the guidewire lumen.The proximal device portion including device hub is missing.The balloon has been inflated and was deflated in the as returned state.The device shaft is severely deformed over a length of 75 mm in its proximal portion.In order to remove the guidewire, the device was partially dissected but the cause for the blockage of the guidewire could not be identified.Microscopic inspection of the guidewire revealed severe damages of the coating at several locations which may have contributed to the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.During final inspection, a 100 percent control of the guidewire lumen viability is performed.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be determined.Please note that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage, bending or kinking of the catheter shaft.

• Brand Name: PASSEO-18 2.5/150/130
• 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: 19557066
• Report Number: 1028232-2024-03238
• Device Sequence Number: 6806428
• Product Code: LIT
• UDI-Device Identifier: 07640130414723
• UDI-Public: (01)07640130414723(17)2504
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K072765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 04/30/2025
• Device Model Number: 366130
• Device Catalogue Number: 366130
• Device Lot Number: 04225245
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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