MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/40/150; PERIPHERAL DILATATION CATHETER

Model Number	366118
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 peripheral balloon catheter was selected for treatment of a moderately calcified lesion (60 percent stenosis degree) in the popliteal artery and proximal ata.The affected device was flushed with saline, followed by insertion of a guidewire from distal direction.The device was then positioned at the distal poplitea and inflated up to 6 atm (np) but the balloon did not open.Blood was noted flowing back into the inflation device.The physician suspected a balloon burst and withdrew the device.A passeo-14 2/40/150 was used to continue 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 the reported event.The technical investigation showed that the balloon has been partially in- and deflated.Microscopic inspection revealed a tear in the balloon at the distal end of the distal radiopaque marker.In close vicinity to the tear, scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G., anatomical structure.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each device is tested for air tightness by means of a pressure test and a helium leak test.We can confirm that the device was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: PASSEO-18 2/40/150
• 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: 20539985
• Report Number: 1028232-2024-05594
• Device Sequence Number: 15508646
• Product Code: LIT
• UDI-Device Identifier: 07640130414600
• UDI-Public: (01)07640130414600(17)2706
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 10/25/2024

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: 366118
• Device Catalogue Number: 366118
• Device Lot Number: 05243011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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