MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/120/90; PERIPHERAL DILATATION CATHETER

Model Number	366105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was selected for treatment of a high-grade calcified stenosis in the posterior tibial artery.After inflation and deflation, the device was attempted to be withdrawn but the device fractured (was torn) inside the introducer sheath.The device was retrieved.No part remained in patient.
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 affected device was returned fractured in two parts.The balloon has been in and deflated and was returned torn in two parts.The distal device fragment has a length of about 132 mm.The proximal device fragment has a length of about 859 mm.The inner shaft has fractured about 2 mm proximal to the proximal radiopaque marker and is severely deformed just distal to the proximal radiopaque marker as well as at the fracture site.The inner shaft diameter does not comply anymore with the specification.The guidewire and the introducer sheath used in the intervention were not returned.Review of the production documentation confirmed that the device was manufactured according to specifications and successfully passed all in process inspections as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be determined.The device most likely fractured as a result of tensile overload during withdrawal into the introducer sheath.Please note that the ifu advises the user to remove the dilatation catheter and the introducer sheath together if resistance is experienced.

• Brand Name: PASSEO-18 2/120/90
• 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: 20398703
• Report Number: 1028232-2024-05261
• Device Sequence Number: 3379039
• Product Code: LIT
• UDI-Device Identifier: 07640130414471
• UDI-Public: (01)07640130414471(17)2706
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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 Model Number: 366105
• Device Catalogue Number: 366105
• Device Lot Number: 05245322
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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