MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 3/150/130; PERIPHERAL DILATATION CATHETER

Model Number	366131
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for pre-dilatation of a severely calcified lesion (95 percent stenosis degree) in a severely tortuous ostial right sfa.Despite pre-dilatation, the lesion could not be crossed with the device.
Additional Manufacturer Narrative
Neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: PASSEO-18 3/150/130
• 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: 20225495
• Report Number: 1028232-2024-04861
• Device Sequence Number: 14294053
• Product Code: LIT
• UDI-Device Identifier: 07640130414730
• UDI-Public: (01)07640130414730(17)2605
• 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): 10/09/2024

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: 05/03/2026
• Device Model Number: 366131
• Device Catalogue Number: 366131
• Device Lot Number: 04231551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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