MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.5/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367019
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo coronary balloon catheter was selected for treatment.Difficulties were experienced in withdrawing the pantera leo over a guide wire.Both devices had to be removed together.
Additional Manufacturer Narrative
The returned instrument was subjected to a detailed 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 instrument was returned with the guidewire still inserted.About 181 mm of the guidewire protrude from the device tip.The guidewire is stuck and cannot be removed.Microscopic inspection revealed that the guidewire is damaged, starting about 42 mm proximal to its distal end.In the damaged zone the coil of the guidewire has unwound which causes a blockage of the guidewire inside the guidewire lumen of the instrument.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 manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the damaged guidewire used in the intervention.

• Brand Name: PANTERA LEO 3.5/15
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11350936
• Report Number: 1028232-2021-00877
• Device Sequence Number: 11773485
• Product Code: LOX
• UDI-Device Identifier: 07640130415775
• UDI-Public: 07640130415775
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 11/30/2023
• Device Model Number: 367019
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11206139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1