MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 3/40/90; PERIPHERAL DILATATION CATHETER

Model Number	357459
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was selected for treatment.The catheter was inserted into the patient and when using the inflation device, no pressure could be built up because the y-connector of the balloon catheter was leaking, and the fluid came out before any pressure could be built up.Another balloon was used and the intervention could be completed successfully.
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 confirmed that the passeo-18 balloon is leaking from a gluing hole in the hub.Microscopic investigation revealed a gap on the gluing interface between hub and inner shaft causing the leakage.The respective internal departments were informed to address the issue accordingly.

• Brand Name: PASSEO-18 3/40/90
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16103946
• Report Number: 1028232-2023-00070
• Device Sequence Number: 18051411
• Product Code: LIT
• UDI-Device Identifier: 07640119558707
• UDI-Public: (01)07640119558707(17)2508
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 08/02/2025
• Device Model Number: 357459
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06224049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown