MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 6/80/130; PERIPHERAL DILATATION CATHETER

Model Number	366124
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen to dilate a severely calcified lesion (100 percent stenosis degree) in a mildly tortuous mid sfa.During inflation, the balloon ruptured after 60 seconds at 12 atm.
Additional Manufacturer Narrative
The complaint instrument was not provided for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Further, the provided angiographic material was reviewed.The provided angiographic material was reviewed but did not lead to any further information regarding the nature of the complaint since the complaint event is not visible in the angiographic material.The presence of a severe calcification could be confirmed.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.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 external factors during procedure.Taking into account the physicians statement to the calcified lesion and the appearance of the calcification in the angiographic film, is assumed that the balloon burst was most likely induced by the severely calcified lesion.

• Brand Name: PASSEO-18 6/80/130
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9316549
• Report Number: 1028232-2019-05009
• Device Sequence Number: 14043438
• Product Code: LIT
• UDI-Device Identifier: 07640130414662
• UDI-Public: 07640130414662
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072765
• 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): 11/05/2019

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 Model Number: 366124
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01191722
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1