MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 1.5/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 393299

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

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

The pantera pro compliant balloon catheter was selected for treatment of a severely calcified lesion with 95 percent stenosis degree.When pushing the balloon catheter to the lesion site, the proximal end of the catheter was bent.The device could not pass through the calcified lesion.

Manufacturer Narrative

The returned product was subjected to a detailed 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 instrument was returned without its packaging.The hypotube is severely kinked at two locations 100 cm proximal to the tip and 2 mm distal to the kink protector.The balloon has been inflated and was returned in a partially deflated state.The remaining instrument shows no damage or irregularities.Review of the product release 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.

• Brand Name: PANTERA PRO 1.5/15
• 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: 17163799
• MDR Text Key: 317487275
• Report Number: 1028232-2023-03086
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 07640130437036
• UDI-Public: (01)07640130437036(17)2509
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393299
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07224201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2022
• 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