MAUDE Adverse Event Report: CREAGH MEDICAL LTD. ADVANCE SERENITY¿ 18; PTA CATHETER

Model Number	SER18-150-25-220
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
"the balloon burst while in the patient.User removed the device and used another balloon (competitor device) to complete the procedure successfully.Pedal access.User was using the balloon at the posterial tibial trunk.The lesion was a highly calcified lesion.They used the balloon over a.014 viper wire.The sheath was a 4/5fr slender by terumo.Balloon burst at 6 atm (below nominal); initial believes it punctured rather than ripped.".
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: ADVANCE SERENITY¿ 18
• 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: 11971252
• Report Number: 3005994106-2021-00011
• Device Sequence Number: 19875234
• Product Code: LIT
• UDI-Device Identifier: 05391525784120
• UDI-Public: 05391525784120
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K180007
• 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): 06/09/2021

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: 11/02/2023
• Device Model Number: SER18-150-25-220
• Device Lot Number: 22002627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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