MAUDE Adverse Event Report: CREAGH MEDICAL LTD. BIOTRONIK PASSEO-35 HP; PTA CATHETER

Model Number	399096
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During inflation the balloon burst occured longitudinally at 16atm.The balloon was successfully retrieved without complication.
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: BIOTRONIK PASSEO-35 HP
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: mike dunning ; ida business park; balinasloe, co. galway, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 11879574
• Report Number: 3005994106-2021-00002
• Device Sequence Number: 17147628
• Product Code: LIT
• UDI-Device Identifier: 05391525781600
• UDI-Public: 05391525781600
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K113468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 05/12/2023
• Device Model Number: 399096
• Device Catalogue Number: 399096
• Device Lot Number: 22000004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• 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: Female