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

Model Number 366127

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2019

Event Type  malfunction  

Event 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.

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
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9071218
• MDR Text Key: 164674222
• Report Number: 1028232-2019-04022
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130414693
• UDI-Public: 07640130414693
• Combination Product (y/n): N
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1