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

Model Number	SER18-150-30-80
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the balloon catheter was returned in two separate segments.One containing the balloon/catheter tip and the other containing the catheter main body.Analysis confirmed the reported issue.The balloon separated at the balloon/catheter body bond.
Event or Problem Description
The balloon catheter was used during an angioplasty procedure in which a venogram and iliac vein stenting were conducted.During the procedure the balloon ruptured and sheared off inside the patient.The patient had a previously placed stent in the iliac vein extending into the inferior vena cava (ivc).The distal end of the sent (in the ivc) was occluded and difficult to cross with the guidewire and catheter.Once crossed, the balloon catheter was advanced over the wire.The target vessel was reported to be "very tight" with a lesion length of approximately 5cm.The balloon rupture occurred approximately 10-15 minutes into the procedure.The balloon was only used for the initial inflation in which the nominal pressure (8atm) was not reached.The type of inflation device used was not recorded.The balloon catheter separated from the shaft during removal and a snare was required.The balloon fragment was lodged at the distal end of a wall stent located in the inferior vena cava (ivc).A loop snare was used to successfully retrieve the segment.A high pressure balloon was advanced over the guidewire, however, the shaft length was not long enough to reach the lesion.A competitor balloon catheter was then advanced over the wire, but it also ruptured at the same location.However, that balloon was able to be removed as a complete catheter.No medical intervention was required and the patient had not adverse effects.The site was unable to balloon the target location during the procedure.The reported issue resulted in an unreported extended procedure length.There was no reported adverse effects to the patient.The length of procedure delay was not recorded.The balloon catheter was prepped per ifu.There was no indication of device damage during preparation.It was noted negative pressure was not held on the balloon while loading and advancement to the target lesion.The site denied torquing/twisting the device during loading and advancement.

• 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: 20114820
• Report Number: 3005994106-2024-00011
• Device Sequence Number: 7220951
• Product Code: LIT
• UDI-Device Identifier: 05391525784168
• UDI-Public: 05391525784168
• 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): 08/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SER18-150-30-80
• Device Lot Number: 22301898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown