MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/8; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	366993
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo coronary balloon catheter was selected for treatment of a lesion (99 percent stenosis degree in the rca.The device was advanced to the lesion and inflated, but ruptured at 18 atm.Another balloon with same size was used afterwards.
Additional Manufacturer Narrative
The returned device was subjected to a detailed technical analysis and the corresponding product release 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 burst longitudinally over a length of about 6 mm.Microscopic inspection of the balloon surface showed several scratches in close vicinity of the tear.It therefore seems likely that the tear was caused by a hard, sharp-edged object pressing against the balloon from the outside.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.Based on the conducted investigations, no material or manufacturing related root cause was determined.The root cause for the complaint event is most likely related to the patients anatomy.

• Brand Name: PANTERA LEO 2.5/8
• 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: 12305020
• Report Number: 1028232-2021-04491
• Device Sequence Number: 14726792
• Product Code: LOX
• UDI-Device Identifier: 07640130415515
• UDI-Public: 07640130415515
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 07/31/2023
• Device Model Number: 366993
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08200080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1