MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 2.0/20; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 393307

Device Problem Material Deformation (2976)

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

Event Date 09/30/2020

Event Type  malfunction  

Event Description

The pantera pro balloon catheter was chosen for the treatment.During preparation it was not possible to insert the guidewire into the guidewire lumen of the pantera pro and the tip of the balloon catheter seemed to be damaged.

Manufacturer Narrative

The returned product was subjected to a 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.The technical investigation revealed that the device tip is severely deformed and has necked near the tip weld.The balloon is well folded and shows no signs of inflation.The transportation wire was not returned for analysis.I in simulations with reference instruments a similar damage pattern as observed in the returned instrument could be reproduced by wrong handling (e.G.Grabbing the balloon protector in the tip area when pulling).However, inside the tip of the returned instrument dried contrast medium was observed which may have contributed to the complaint event.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Every instrument is shipped with a 0.015 inch transportation wire that covers the full guidewire lumen.No difficulties in removing the transportation wire have been reported.The instrument was in accordance with the specifications at the time of delivery.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: PANTERA PRO 2.0/20
• Type of Device: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10740550
• MDR Text Key: 213205505
• Report Number: 1028232-2020-04645
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 07640130437111
• UDI-Public: 07640130437111
• Combination Product (y/n): N
• PMA/PMN Number: K160985
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: 393307
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05191421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1