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	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo coronary balloon catheter was selected for treatment.After withdrawal of the device it was observed that the hypotube of the catheter was frayed at about 25 cm from guide wire exit port.
Additional 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.In addition, the provided angiographic material was reviewed.The technical investigation revealed that the hypotube is damaged 21 cm proximal to the guidewire exit port over a length of 4.5 mm.The damage appears like a cut caused by a sharp object (e.G.A scalpel) into distal direction.The balloon has clearly been inflated.The provided angiographic material was reviewed.The actual complaint event is not visible.The angiographic material does therefore not provide further relevant information regarding the root cause of the complaint.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.The hypotube is inspected numerous times for damages of the hypotube coating.The instrument was in accordance with the specifications at the time of delivery.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• 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: 11770513
• Report Number: 1028232-2021-02270
• Device Sequence Number: 14514389
• 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): 05/04/2021

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: 02/29/2024
• Device Model Number: 367019
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02213878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1