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

Model Number 393298

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

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 balloon has been inflated and was returned partially deflated.The device shaft is kinked about 5 mm distal to the guide wire exit port.In addition, the hypotube is kinked about 121 mm and about 144 mm distal to the kink protector.A 0.014 inch reference guidewire could be fully introduced with no unusual friction.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the procedure.Please note that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage, bending or kinking of the catheter shaft.

Event Description

The pantera pro coronary balloon catheter was selected for treatment of a severely calcified lesion (95 percent stenosis degree) in a moderately-severely tortuous part of the distal lcx.The affected device was introduced into the patients body but could not pass the lesion.The physician attempted to push the affected device to the lesion site during which the proximal end of the device was bent.

• Brand Name: PANTERA PRO 1.25/15
• Type of Device: 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: 18975822
• MDR Text Key: 339146298
• Report Number: 1028232-2024-01644
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 07640130437029
• UDI-Public: (01)07640130437029(17)2603
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K160985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393298
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03230654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1