MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.0/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 367006

Device Problem Difficult to Remove (1528)

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

Event Date 10/15/2020

Event Type  malfunction  

Event Description

A pantera leo coronary balloon catheter was selected for treatment.It was difficult to remove the balloon catheter because it did not slide along the guide wire.

Manufacturer Narrative

This report was originally filed without a device lot number and size.The product was returned and the file has been updated with the information.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 deflated in the as-returned state.During analysis a 0.014 inch reference guidewire could be introduced with no unusual friction.A 0.015 inch reference transportation wire could not be fully introduced.Both the outer and inner shaft were found deformed (i.E.Flattened) about 13 cm proximal to device tip.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.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 thus in accordance with the specifications at the time of delivery.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: PANTERA LEO 3.0/12
• Type of Device: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11008156
• MDR Text Key: 221487259
• Report Number: 1028232-2020-05477
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K163660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 367006
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08203586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1