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

Model Number	393303
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera pro coronary dilatation catheter was chosen for treatment of a congenital stenosis in the pulmonary artery of a (b)(6) months old baby.The balloon ruptured at 10 atm.
Additional Manufacturer Narrative
The returned instrument 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 the reported event.The technical investigation revealed that the balloon has burst longitudinal over a length of about 8.5 mm.Microscopic inspection of the balloon surface showed deep scratches in close vicinity of the tear.It therefore seems likely that the tear in the balloon 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.The instrument was delivered in a leak-proof condition.Based on the conducted investigations no manufacturing related root cause could be determined.The root cause is most likely related to the patients anatomy.It should be noted that, according to the ifu, the pantera pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

• Brand Name: PANTERA PRO 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: 11999795
• Report Number: 1028232-2021-03332
• Device Sequence Number: 3560367
• Product Code: LOX
• UDI-Device Identifier: 07640130437074
• UDI-Public: 07640130437074
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160985
• 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): 06/14/2021

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: 10/29/2023
• Device Model Number: 393303
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10204484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1