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

Model Number	SER18-135-60-150
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the balloon catheter was returned for analysis in two segments.Analysis confirmed balloon separation.The first segment included the catheter main body to the manifold of the proximal bond.The second segment included the balloon portion and tip.Observation of the device at the point of balloon separation from the device main body showed severe elongation of both the inner and outer shaft.There was a device length increase of approximately 41.9cm (31%) from the original specification length.
Event or Problem Description
The balloon catheter was used a lower leg angiogram of the superficial femoral artery (sfa).Following crossing the lesion and ballooning, the balloon detached from the catheter and had to be retrieved via a snare.The balloon was fully removed from the patient without harm.The balloon was used to complete the procedure.Additional information indicated the balloon was prepped per ifu and there was no indication of device damage.The site confirmed negative pressure was held during loading and movement to the target lesion.There was no indication of negative pressure loss during loading.The target vessel had moderate calcification with a lesion length of approximately 60-80 mm.The degree of stenosis was noted to be moderate.The reported issue occurred after the initial inflation.The procedure was considered successful.The length of procedure delay was reported to be 10-15 minutes.The patient was reported to be stable without issue.

• 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: 20839621
• Report Number: 3005994106-2024-00016
• Device Sequence Number: 19765567
• Product Code: LIT
• UDI-Device Identifier: 05391525787176
• UDI-Public: 05391525787176
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: SER18-135-60-150
• Device Lot Number: 22400515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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 Sex: Unknown