MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/200/150; PERIPHERAL DILATATION CATHETER

Model Number 376296

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/03/2021

Event Type  malfunction  

Event Description

A passeo-18 balloon catheter was chosen for pre-dilatation, but the balloon could not be inflated properly and upon removal a balloon leakage was detected.Another passeo-18 was used to finish the treatment.

Manufacturer Narrative

The returned instrument was subjected to a technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed a fine jet of water emerging from the distal end of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole at the distal end of the distal x-ray marker.At the origin of the pinhole several longitudinal deep scratches were observed.It therefore seems likely that the damage of the balloon surface was caused by a hard, sharp-edged object pressing against the balloon from the outside.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.

• Brand Name: PASSEO-18 2/200/150
• 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: 12050600
• MDR Text Key: 257771642
• Report Number: 1028232-2021-03498
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130430037
• UDI-Public: 07640130430037
• Combination Product (y/n): N
• PMA/PMN Number: K151744
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 376296
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11203344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1