MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 1.25/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393298
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera pro coronary dilatation catheter was chosen for treatment of a severely calcified lesion (80 percent stenosis degree) in the mildly tortuous distal lad.The device could not pass the lesion and was deformed.
Additional Manufacturer Narrative
The returned product was subjected to a technical analysis and the corresponding product release 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 (i.E.Elongated and constricted) near the tip weld.The balloon is well folded and shows no signs of inflation.The transportation wire and the protector is undamaged and shows no irregularities.Review of the product release 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 1.25/15
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14579586
• Report Number: 1028232-2022-02844
• Device Sequence Number: 5492137
• Product Code: LOX
• UDI-Device Identifier: 07640130437029
• UDI-Public: 07640130437029
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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: 10/14/2022
• Device Model Number: 393298
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10191106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown