MAUDE Adverse Event Report: CREAGH MEDICAL BIOTRONIK PASSEO-35 HP; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	399084
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device was returned and analysis was anticipated, but had not yet began.A supplemental mdr will be submitted following analysis completion.
Event or Problem Description
The balloon catheter was used for a radial artery angioplasty.The balloon ruptured before the angioplasty could be performed.The patient was discharged home.There was no patient harm.No further information was provided.
Additional Manufacturer Narrative
H3: the balloon catheter was returned for analysis.Analysis confirmed a device issue.A cut/tear was observed approximately 2cm distal to the proximal catheter bond.
Event or Problem Description
Additional information received from the distributor indicated the procedure was initially a fistulogram that required angioplasty.The balloon was reportedly prepped per ifu.The vessel calcification, degree of stenosis, and lesion length were not available.The issue occurred at the beginning of the procedure.The inflation pressure at the time of rupture was not recorded.The procedure was stated to have gone well with the use of another balloon.The patient was reportedly fine.

• Brand Name: BIOTRONIK PASSEO-35 HP
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 19333302
• Report Number: 3005994106-2024-00007
• Device Sequence Number: 3102437
• Product Code: LIT
• UDI-Device Identifier: 05391525781488
• UDI-Public: 05391525781488
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2024

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: 10/09/2025
• Device Model Number: 399084
• Device Lot Number: 22202257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 05/21/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/06/2024; 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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 Age: 33 YR
• Patient Sex: Female