MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 6/40/80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 357289

Device Problem Material Rupture (1546)

Patient Problem Injury (2348)

Event Date 06/22/2020

Event Type  Injury  

Event Description

The passeo-35 balloon was selected for treatment of an arteriovenous fistula dysfunction.After positioning the balloon was inflated up to 16 atm.During attempt to inflate a 2nd time with same pressure, the balloon ruptured and could not be withdrawn and was retrieved with an incision.

Manufacturer Narrative

The complaint instrument was not returned 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.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 and a pressure test.The instrument was delivered in a leak-proof and pressure-tight condition.Based on the conducted investigations no manufacturing related root cause could be determined.

• Brand Name: PASSEO-35 6/40/80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10484028
• MDR Text Key: 205337827
• Report Number: 1028232-2020-03731
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 07640119558189
• UDI-Public: 07640119558189
• Combination Product (y/n): N
• PMA/PMN Number: K082933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 357289
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09191054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1