MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 4/80/130; PERIPHERAL DILATATION CATHETER

Model Number 357505

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/10/2021

Event Type  malfunction  

Event Description

A passeo-18 balloon catheter was selected for treatment.The balloon was placed properly in the lesion.It was attempted to inflate the balloon as usual.Going up to np was possible without problems but when arriving at 5 atm, the pressure of the balloon would slowly turn down.To keep the balloon inflated at 5 atm more pressure needed to be applied.A new balloon was used to complete the intervention.

Manufacturer Narrative

The returned instrument 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 the reported event.The technical investigation revealed that the balloon has burst longitudinal over a length of about 51 mm.Microscopic inspection of the balloon showed several deep scratches in close vicinity of the tear.It seems likely that the tear in the balloon was caused by a hard, sharpedged object pressing against the balloon from the outside.Review of the production 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 a pressure test and 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 material or manufacturing related root cause was determined.The root cause is most likely related to the patients anatomy.

• Brand Name: PASSEO-18 4/80/130
• 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: 11980305
• MDR Text Key: 255541559
• Report Number: 1028232-2021-03299
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640119559162
• UDI-Public: 07640119559162
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 357505
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09201172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1