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

Model Number	393307
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1028232-2020-04645
• Device Sequence Number: 19598225
• Product Code: LOX
• UDI-Device Identifier: 07640130437111
• UDI-Public: 07640130437111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1