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

Model Number 380350

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

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.During the technical investigation the reported complaint event could be reproduced.Upon flushing the guidewire lumen, water emerged from the inflation port.In addition, a balloon pinhole was detected.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.Review of the production documentation confirmed that the product was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each product is tested for air tightness by means of a helium leak test.We can therefore confirm that the product was delivered in a leak-proof condition.

Event 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, and a hub leakage was detected.During the technical investigation a balloon pinhole was observed.The pinhole did not occur due to the reported complaint event.The hub leakage was detected by the physician, but the pinhole remained undetected.

• Brand Name: PASSEO-14 2/220/150
• Type of Device: 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: 18535660
• MDR Text Key: 333213963
• Report Number: 1028232-2024-00344
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130433861
• UDI-Public: (01)07640130433861(17)2608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380350
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06235011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization