MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 5.0/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367012
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo balloon catheter was chosen for treatment.The balloon ruptured during inflation and it was impossible to remove the balloon.A lasso has been used to remove the balloon from the patients body.
Additional Manufacturer Narrative
The returned device 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 technical investigation revealed that the returned instrument has fractured at the proximal end of the guide wire exit port.The fracture site is plastically deformed.The plastically deformation is indicating a mechanical overload during withdrawal.Review of the production documentation verified that the instrument detailed above was manufactured according to specifications.The device fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no material or manufacturing related root cause could be identified.The device fracture most likely occurred due to a mechanical overload during withdrawal.

• Brand Name: PANTERA LEO 5.0/12
• 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: 9446216
• Report Number: 1028232-2019-05489
• Device Sequence Number: 14013972
• Product Code: LOX
• UDI-Device Identifier: 07640130415706
• UDI-Public: 07640130415706
• 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): 12/10/2019

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: 08/31/2022
• Device Model Number: 367012
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09192176
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1