MAUDE Adverse Event Report: CREAGH MEDICAL LTD. ADVANCE SERENITY¿ 14; PTA CATHETER

Model Number	SER14-150-20-100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon ruptured when inflated for multiple times to a maximum burst pressure of 16atm.No injury caused to the vessel.
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: ADVANCE SERENITY¿ 14
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: mike dunning ; ida business park; balinasloe, co. galway, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 12205943
• Report Number: 3005994106-2021-00013
• Device Sequence Number: 4742607
• Product Code: LIT
• UDI-Device Identifier: 05391525784762
• UDI-Public: 05391525784762
• 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): 07/21/2021

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: 04/21/2023
• Device Model Number: SER14-150-20-100
• Device Lot Number: 21904477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2021
• Supplement Date Received by Manufacturer: 06/20/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2020
• 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: Male