MAUDE Adverse Event Report: CREAGH MEDICAL ADVANCE SERENITY 014; PERIPHERAL ANGIOPLASTY BALLOON CATHETER, BASIC

Model Number	SER14-150-25-100
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sales rep, (b)(6), reported on (b)(6) 2022 - the balloon burst (12 atm) before the rated burst level (16 atm).No part separated in the patient.The balloon was removed and physician was able to successfully completed the procedure with another device of the same type (different size).The balloon was used over a.014, 300 cm cook hydro st wire during a tibial angioplasty procedure.Initial containment activities indiciate there are no other suspect products in the field.Device evaluation is expected but not started.
Event or Problem Description
Per rep - on (b)(6) 2022 - the balloon burst (12 atm) before the rated burst level (16 atm).No part separated in the patient.They removed the balloon and successfully completed the procedure with another device of the same type (different size).The balloon was used over a.014, 300 cm cook hydro st wire.Type of procedure: tibial angioplasty.

• Brand Name: ADVANCE SERENITY 014
• Common Device Name: PERIPHERAL ANGIOPLASTY BALLOON CATHETER, BASIC
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway, ireland ; EI
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway, ireland ; EI
• Manufacturer Contact: holly ramirez ; 7905 golden triangle drive; eden prairie, MN 55344
• MDR Report Key: 15041569
• Report Number: 3005994106-2022-00003
• Device Sequence Number: 12037813
• Product Code: LIT
• UDI-Device Identifier: 05391525784830
• UDI-Public: 05391525784830
• Combination Product (Y/N): N
• PMA/510(K) Number: K171251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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: 02/29/2024
• Device Model Number: SER14-150-25-100
• Device Lot Number: 22100455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2021
• 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: Female