MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 2/220/150; PERIPHERAL DILATATION CATHETER

Model Number	380350
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-14 balloon catheter was chosen for treatment of a mildly calcified lesion (70 percent stenosis degree) in a mildly tortuous part of the mid tibial artery.The affected device was introduced into the patients body and advanced to the area of interest.Once positioned, the balloon was inflated with a maximum pressure of 8 atm.Thereafter, the 0.014 inch guidewire was removed.The physician took a 3cc syringe with 0.5 ml contrast medium and 2 ml saline and injected the solution through the guidewire port during which the solution was seen to emerge from the balloon port of the affected device.
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.The affected balloon has been inflated and was deflated in the as returned state.Upon inflation the balloon opened normally but the pressure did not hold.A fine jet of water was seen to emerge from the distal balloon portion.Microscopic inspection revealed a pinhole about 11 mm proximal to the distal x-ray marker.In close vicinity to the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G., anatomical structure.A hub leakage as described in the event description could not be confirmed.Review of the production documentation confirmed 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 was determined.The root cause for the complaint event is most likely related to the patients anatomy.

• Brand Name: PASSEO-14 2/220/150
• 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: 18437194
• Report Number: 1028232-2024-00017
• Device Sequence Number: 6959571
• Product Code: LIT
• UDI-Device Identifier: 07640130433861
• UDI-Public: (01)07640130433861(17)2606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: 06/27/2026
• Device Model Number: 380350
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05233404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown