MAUDE Adverse Event Report: CREAGH MEDICAL LTD ADVANCE SERENITY¿; PTA CATHETER

Model Number	PN00883-42
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During intervention procedure, catheter and sheath are positioned up, the guidewire is inserted from groin and pedal access.Due to longer wire length and balloon length kelly clamp was used.The balloon was inflated twice and the inflation worked fine.But while removing the balloon, it was sheared in to multiple segments.The patient was not able to be treated for the obstructions and required a hospital stay after the extended procedure necessary to remove the balloon fragments.No serious harm came to the patient.
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: ADVANCE SERENITY¿
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; ida business park,; ballinasloe, co. galway,; EI
• Manufacturer (Section G): CREAGH MEDICAL LTD; ida business park,; ballinasloe, co. galway; EI
• Manufacturer Contact: holly ramirez ; 7905 golden triangle, dr # 190; eden prairie, mn, 55344
• MDR Report Key: 13254339
• Report Number: 3005994106-2022-00001
• Device Sequence Number: 4533335
• Product Code: LIT
• UDI-Device Identifier: 05391525784786
• UDI-Public: 05391525784786
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K171251
• 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): 01/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2024
• Device Model Number: PN00883-42
• Device Lot Number: 22101992
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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