MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 6/120/130; PERIPHERAL DILATATION CATHETER

Model Number	366127
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen to dilate a severe calcified lesion (70 percent stenosis degree) in the distal sfa.During inflation the passeo-18 balloon ruptured.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was provided for analysis.Therefore no technical investigation on the subject could be performed.The manufacturing history was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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.

• Brand Name: PASSEO-18 6/120/130
• 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: 9071218
• Report Number: 1028232-2019-04022
• Device Sequence Number: 2243529
• Product Code: LIT
• UDI-Device Identifier: 07640130414693
• UDI-Public: 07640130414693
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: 01/31/2022
• Device Model Number: 366127
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02192165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1