MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 5/60/80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	357294
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 balloon was selected for treatment of a calcified lesion in the rca.During the intervention it was noticed that the balloon is perforated in the middle and could not be used.
Additional Manufacturer Narrative
The returned instrument was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation of the returned device revealed a fine jet of water emerging from the medial balloon part when attempting inflation.Microscopic analysis of the balloon surface showed a microscopic leakage about 26 mm proximal to the distal x-ray marker.Scratches were observed in the balloon surface nearby the damage site.It seems likely that the damage of the balloon surface was caused by a hard, sharp-edged object pressing against the balloon from the outside.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.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.

• Brand Name: PASSEO-35 5/60/80
• 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: 10014423
• Report Number: 1028232-2020-01891
• Device Sequence Number: 2436964
• Product Code: DQY
• UDI-Device Identifier: 07640119558233
• UDI-Public: 07640119558233
• 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): 04/29/2020

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: 12/31/2022
• Device Model Number: 357294
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12193812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1