MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 2.5/10; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393294
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera pro coronary dilatation catheter was chosen for treatment.During deflation the device got stuck on the guide wire and could not be withdrawn.Finally the device was removed together with the guide wire.
Additional 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 inflation lumen of the pantera pro is occluded at the guidewire exit port.Functional testing was unsuccessful.The balloon could not be inflated.Microscopic inspection showed that the dimensions of the guidewire exit port welding are not adequate which impedes inflation of the balloon.To prevent recurrence the respective internal departments were informed about this case and we are reviewing our quality systems processes.

• Brand Name: PANTERA PRO 2.5/10
• 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: 10315775
• Report Number: 1028232-2020-03046
• Device Sequence Number: 1045000
• Product Code: LOX
• UDI-Device Identifier: 07640130436985
• UDI-Public: 07640130436985
• 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): 07/23/2020

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: 05/13/2022
• Device Model Number: 393294
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05190656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1