MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 6/200/130; PERIPHERAL DILATATION CATHETER

Model Number 376302

Device Problem Decrease in Pressure (1490)

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

Event Type  malfunction  

Event Description

A passeo-18 balloon catheter was chosen for treatment.It was attempted to inflate the balloon up to 5 bar, but to keep it at 5 bar it was necessary to give more pressure.Eventually the passeo-18 had to be replaced by another balloon as it could not be used anymore.Lot number and event date are unavailable.

Manufacturer Narrative

Only the material number was reported whereas the affected instrument was discarded.Even after additional correspondence with the local staff, neither a lot number nor an event date could be obtained.An investigation with regards to the reported complaint event could therefore not be performed.During the manufacturing process, every lot is tested by predefined specifications in the in-process and final inspections.During final inspection, each instrument is tested for air tightness by means of a helium leak test and a pressure test.

• Brand Name: PASSEO-18 6/200/130
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 12252848
• MDR Text Key: 264301858
• Report Number: 1028232-2021-04306
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130430099
• UDI-Public: 07640130430099
• Combination Product (y/n): N
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 376302
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1