MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 6/80/90; PERIPHERAL DILATATION CATHETER

Model Number	357474
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was selected for treatment of the superficial femoral artery (sfa).After inflation of the balloon it was impossible to remove it from the patient.During withdrawal the balloon broke inside a 4f introducer sheath.
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 instrument was returned fractured in two parts.The distal fragment is stuck inside the 4f terumo introducer sheath used in the intervention.About 1.5 cm of the instrument protrude from the distal end of the introducer sheath.Dried contrast medium and blood residue was observed in the balloon lumen.The balloon is slipped over in distal direction.At the proximal fragment the device shaft is severely deformed (i.E.Elongated and constricted), indicating application of a high tensile force.Due to the state of the instrument the in and deflation behavior could not be investigated.The returned introducer sheath is severely deformed at its distal end and kinked proximally.Review of the lot release verification confirmed that the complaint instrument was manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The balloon was most probably not fully deflated when pulling it back into the introducer sheath, and the instrument then fractured as a result of tensile overload.It should be noted that the ifu instructs the user to deflate balloons exceeding 3.5 mm diameter and 60 mm length for at least 90 seconds and to maintain vacuum whenever the dilatation catheter is subsequently advanced or withdrawn.Failure to do so may result in difficulties pulling back the balloon through the introducer sheath.

• Brand Name: PASSEO-18 6/80/90
• 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: 11348501
• Report Number: 1028232-2021-00845
• Device Sequence Number: 14094369
• Product Code: LIT
• UDI-Device Identifier: 07640119558851
• UDI-Public: 07640119558851
• 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): 02/12/2021

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: 09/30/2023
• Device Model Number: 357474
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10201838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1