MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 2.0/10; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393293
Medical Device Problem Code	Inflation Problem (1310)
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.The balloon could not be inflated.Another device was used to finish the treatment.
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 guidewire is stuck in the guidewire lumen of the complaint instrument and cannot be removed.The diameter of the guidewire was measured and found to be compatible with the complaint instrument according to the ifu (0.014 inch/0.36 mm).Microscopic inspection revealed that the guidewire is severely deformed in three areas.In these areas the coil of the guidewire is unwound and is overlapping inside the guidewire lumen forming a thickened area which most likely causes the blockage of the guidewire.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes a removal of the auxiliary wire and an insertion of a transportation wire to ensure a free guidewire lumen.Further, the protector removal force of a defined amount of samples is tested from every lot.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the unwound guidewire.

• Brand Name: PANTERA PRO 2.0/10
• 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: 10315771
• Report Number: 1028232-2020-03045
• Device Sequence Number: 11024147
• Product Code: LOX
• UDI-Device Identifier: 07640130436978
• UDI-Public: 07640130436978
• 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: 09/29/2022
• Device Model Number: 393293
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09196002
• 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: 11/02/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1