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

Model Number	8/80/75
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During procedure on (b)(6) 2022, the 8x80mm balloon was being used to treat a lesion in the proximal section of the bcf.Calcification is recorded as moderate.Upon inflation of the balloon inside the patient, the balloon burst at 21 atm on the first inflation attempt.No segments of the balloon were left inside patient, and patient was later discharged home without further complications or medical intervention.
Event or Problem Description
Balloon burst at 21 atm.First inflation.
Additional Manufacturer Narrative
Correction: b5 updated.H3: hardware analysis confirmed the reported issue.The balloon had burst longitudinally.The burst traveled the length of the balloon and terminated at the proximal balloon cone and distal sleeve respectively.H6: code a041001 (1504) no longer applies to the event.
Event or Problem Description
During procedure on (b)(6) 2022, the 8x80mm balloon was being used to treat a lesion in the proximal section of the brachiocephalic fistula (bcf).Calcification is recorded as moderate.Upon inflation of the balloon inside the patient, the balloon burst at 21 atm on the first inflation attempt.No segments of the balloon were left inside patient, and patient was later discharged home without further complications or medical intervention.Additional information received indicated the balloon was prepped per indications for use.The reported issue occurred in a venoplasty procedure.The target vessel had moderation calcification (approximately 25%).There was no impact to patient outcome.
Event or Problem Description
Additional information received indicated the procedure was successfully completed with the use of a competitor 8mm balloon.It was noted the balloon was used to treat an area not at the actually arteriovenous fistula (avf) anastomotic site.

• Brand Name: BIOTRONIK PASSEO-35HP
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road, balliinasloe; co. galway, ireland H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road, balliinasloe; co. galway, ireland H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: holly ramirez ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007000
• MDR Report Key: 15789008
• Report Number: 3005994106-2022-00009
• Device Sequence Number: 14820726
• Product Code: LIT
• UDI-Device Identifier: 05391525781587
• UDI-Public: 05391525781587
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2023

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: 08/30/2023
• Device Model Number: 8/80/75
• Device Catalogue Number: 399094
• Device Lot Number: 22002246
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 01/13/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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