MAUDE Adverse Event Report: CREAGH MEDICAL ADVANCE SERENITY¿ 18; Catheter, angioplasty, peripheral, transluminal

Model Number	SER18-135-50-80
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
The device was being used in the right superficial femoral artery (sfa) post an atherectomy procedure.The balloon catheter ruptured when inflated to 10atm.No resistance was experienced during balloon placement.The vessel was reported to be highly calcified with a lesion length of approximately 80mm and stenosis of a degree of 80%.The procedure was completed with the use of another balloon.The patient did not require any additional procedures.There was no impact to patient outcome and no patient harm.The reported issue did not result in a procedure delay.

• Brand Name: ADVANCE SERENITY¿ 18
• 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: 17813959
• Report Number: 3005994106-2023-00008
• Device Sequence Number: 15266206
• Product Code: LIT
• UDI-Device Identifier: 05391525787060
• UDI-Public: 05391525787060
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2023

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: 02/26/2026
• Device Model Number: SER18-135-50-80
• Device Lot Number: 22202855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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: 80 YR
• Patient Sex: Male