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

Model Number	357289
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Event or Problem 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inflated up to 16 atm.During attempt to inflate a 2nd time with same pressure, the balloon ruptured and could not be withdrawn and was retrieved with an incision.
Additional 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10484028
• Report Number: 1028232-2020-03731
• Device Sequence Number: 3028907
• Product Code: DQY
• UDI-Device Identifier: 07640119558189
• UDI-Public: 07640119558189
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082933
• 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): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1