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

Model Number	10/40/75
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported to manufacturer that "balloon did not deflate properly".Device was not returned for evaluation.There was no patient harm reported.
Event or Problem Description
On 08sep2022, manufacturer became aware of the event, described as "balloon did not deflate properly".Procedure was performed on (b)(6) 2022.

• Brand Name: BIOTRONIK PASSEO-35 HP
• 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: 15510236
• Report Number: 3005994106-2022-00005
• Device Sequence Number: 20289858
• Product Code: LIT
• UDI-Device Identifier: 05391525781600
• UDI-Public: 05391525781600
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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
• Device Expiration Date: 09/07/2024
• Device Model Number: 10/40/75
• Device Catalogue Number: 399096
• Device Lot Number: 22102063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown