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

Model Number PN00883-42

Device Problems Break (1069); Material Rupture (1546); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  Injury  

Event 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 Description

Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: ADVANCE SERENITY¿
• Type of Device: 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
• MDR Text Key: 290450004
• Report Number: 3005994106-2022-00001
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391525784786
• UDI-Public: 05391525784786
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K171251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: PN00883-42
• Device Lot Number: 22101992
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1