MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 2.0/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ous mdr - while connecting the indeflator to the hub of the pantera pro balloon catheter a hub fracture was noticed.
Additional Manufacturer Narrative
A technical analysis of the returned instrument and a review of the manufacturing history were conducted to evaluate whether there was any deviation that could account for the reported event.The technical investigation of the returned device revealed that the hub has fractured about 3.4cm distal to its proximal end.No flaw is seen that might have a preconditioning for a crack and fracture of the hub.The fracture surfaces appear like an overload fracture.During simulation a similar fracture side could only be induced by bending the hub with high bending force.Review of the production 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.A pre-existing damage of the hub would have been detected.Based on the conducted investigations of the device being subject to this complaint no material or manufacturing related root cause could be identified.

• Brand Name: PANTERA PRO 2.0/15
• 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: 8595440
• Report Number: 1028232-2019-01902
• Device Sequence Number: 2294312
• Product Code: LOX
• UDI-Device Identifier: 07640130437043
• UDI-Public: 07640130437043
• 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): 05/08/2019

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: 05/24/2021
• Device Model Number: 393300
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05180079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1