MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 4/80/130; PERIPHERAL DILATATION CATHETER

Model Number	357505
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for pre-dilatation of a mildly calcified lesion (85 percent stenosis degree) in the moderately tortuous mid sfa, but the device could not pass the lesion.Another balloon was used to finish the procedure.
Additional Manufacturer Narrative
The returned device 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 appears unfolded but shows no signs of inflation as the inflation lumen and the balloon lumen is dry.A slight kink was observed proximal to the proximal x-ray marker, a reference guide wire could be fully introduced.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct folding of the balloon.Further, the balloon crossing profile is verified to 100 percent.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: PASSEO-18 4/80/130
• 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: 20053979
• Report Number: 1028232-2024-04481
• Device Sequence Number: 7955902
• Product Code: LIT
• UDI-Device Identifier: 07640119559162
• UDI-Public: (01)07640119559162(17)2701
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 357505
• Device Catalogue Number: 357505
• Device Lot Number: 01242911
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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