MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 4/40/130; PERIPHERAL DILATATION CATHETER

Model Number	357494
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen for the treatment of a mildly calcified lesion.The balloon ruptured at 5 atm.The balloon could be withdrawn and another balloon was used.
Additional Manufacturer Narrative
The returned instrument was subjected to a detailed 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 revealed that the balloon has burst longitudinal over a length of about 36 mm.Microscopic inspection of the balloon surface showed several scratches in close vicinity of the tear.It seems likely that the tear in the balloon was caused by a hard, sharpedged 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.Based on the conducted investigations, no material or manufacturing related root cause was determined.The root cause is most likely related to the patients anatomy.

• Brand Name: PASSEO-18 4/40/130
• 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: 10681228
• Report Number: 1028232-2020-04437
• Device Sequence Number: 2943211
• Product Code: LIT
• UDI-Device Identifier: 07640119559056
• UDI-Public: 07640119559056
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072765
• 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): 10/14/2020

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: 02/28/2023
• Device Model Number: 357494
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02204726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1