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	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo balloon catheter was chosen for treading a calcified lesion (90 percent stenosis degree) in the rca.After successful treatment, during withdrawal the device fractured.The distal part could be removed with a snare.
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 complaint instrument was returned in two fragments.The hypotube has fractured about 23.3cm distal to the kink protector.Microscopic analysis of the fracture sites showed the cross-section is no longer circular which indicates that the hypotube most likely fractured as a result of significant bending.Other than reported the balloon of the complaint instrument has not been inflated.Review of the production documentations for the product detailed above verified that the instrument was manufactured according to specification and fulfilled all the requirements of in-process and final inspection.During final inspection and inner packaging every device is being visually inspected for kinks.The device was 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 could be determined.It should be noted that the ifu advices to stop the manipulation if a resistance is felt and advancement by force may result in separation of the dilatation catheter.

• 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: 9288255
• Report Number: 1028232-2019-04906
• Device Sequence Number: 2352295
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 04/30/2021
• Device Model Number: 367019
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05180676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1