MAUDE Adverse Event Report: CREAGH MEDICAL ADVANCE SERENITY¿ 14; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	SER14-120-20-40
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon catheter was used during an angioplasty procedure.The balloon burst during inflation.A hole in the balloon was created distally.The reported issue was attributed to heavy plaque calcification of the target vessel.No segments of the device remained inside the patient.The patient did not require any additional procedures.The patient did not experience any adverse effects.There was no reported patient delay.
Additional Manufacturer Narrative
H3: the balloon catheter was returned in two segments for analysis.Analysis confirmed the reported issue.The balloon burst and separated near the distal tip.
Event or Problem Description
Additional information received from the distributor indicated the device was prepped per ifu.There was no indication of damage to the device during preparation.The site denied maintaining negative pressure during loading and advancement to the target lesion.There was moderate stenosis.The balloon rupture occurred after the second inflation.The reported event did not impact the procedure as a competitor balloon was then used.No medical interventions were required.

• Brand Name: ADVANCE SERENITY¿ 14
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 20200180
• Report Number: 3005994106-2024-00012
• Device Sequence Number: 6880286
• Product Code: LIT
• UDI-Device Identifier: 05391525784380
• UDI-Public: 05391525784380
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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 Model Number: SER14-120-20-40
• Device Lot Number: 22400949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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 Age: 68 YR
• Patient Sex: Male