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

Model Number 366129

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/16/2021

Event Type  malfunction  

Event Description

The physician intended to treat a severely calcified lesion (90 percent stenosis degree, vessel reference diameter 6 mm, lesion length 180 mm) in a mildly tortuous bifurcation of the left anterior tibial artery.A passeo-18 balloon catheter was used for the procedure.Initially, it was reported that the balloon of the complaint instrument burst and ruptured in the vessel.After additional correspondence with the local staff it was clarified that the complaint instrument was successfully inflated three times.After balloon deflation, the instrument was withdrawn during which the balloon tore off the catheter.Since the balloon could not be recovered, the patient underwent surgery.The balloon was successfully removed.

• Brand Name: PASSEO-18 2/150/150
• 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: 12370304
• MDR Text Key: 268229971
• Report Number: 1028232-2021-04800
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130414716
• UDI-Public: 07640130414716
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 366129
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11202139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Date Device Manufactured: 11/26/2020
• 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; Required Intervention