MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 1.25/20; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393305
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
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 instrument has fractured in two parts.The fracture sites are located at the proximal balloon weld for the outer shaft and at the guidewire exit port for the inner shaft.The inner shaft is severely elongated and constricted, indicating application of a high tensile force.The exposed inner shaft has been severely deformed over its entire length.In turn, a reference guidewire could not be fully introduced.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations no material or manufacturing related root cause could be identified.The root cause for the complaint event is most likely related to the handling (i.E., application of a high tensile force during withdrawal).It should be noticed that the ifu advice that in case of difficulties during catheter removal, to remove the entire system at once, i.E., the guiding catheter, the guide wire, and the dilatation catheter simultaneously.
Event or Problem Description
The physician intended to treat a moderately calcified lesion in a moderately tortuous segment of an unspecified abdominal vessel.The used accessories were a 4f and a 6f fortress introducer sheath and two guidewires (1x 0.014 inch command hi torque and 1x 0.014 inch glidewire advance).The only information available is that during withdrawal the complaint instrument broke.

• Brand Name: PANTERA PRO 1.25/20
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17363837
• Report Number: 1028232-2023-03629
• Device Sequence Number: 6091432
• Product Code: LOX
• UDI-Device Identifier: 07640130437098
• UDI-Public: (01)07640130437098(17)2602
• 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): 07/20/2023

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: 02/15/2026
• Device Model Number: 393305
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01235880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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