MAUDE Adverse Event Report: CREAGH MEDICAL FIRST CHOICE; Catheter, angioplasty, peripheral, transluminal

Model Number	UHP7594
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the balloon was returned for analysis.Analysis confirmed the balloon burst.The balloon burst transversely with distal segment separation.The missing segment included the distal tip and part of the balloon segment.Both marker bands remained on the returned segment.
Event or Problem Description
The patient present for a fistalgram and angioplasty procedure.It was determined the cephalic arch was approximately 80% stenosed.The high pressure balloon inflations were performed.Moderate waste noted, followed by full effacement at 22atm.The balloon was deflated and easily removed.The stenosis was reevaluated with contrast injection.Significant stenosis presence was identified and stent placement was performed.The balloon was advanced over wire and inflations performed.The balloon was used to fully expand the stent and set in place against the vessel wall.The intention was to inflate the balloon to 20atm.However, the balloon ruptured at 16atm.The balloon was difficult to remove as it appeared to be stuck to newly placed stent.With much difficulty balloon was able to be pulled followed by sheath removal.Examination of the broken balloon was then performed.The balloon was determined to have ruptured transversely with half out of the body and other half remaining inside.The remaining balloon was ultimately able to be removed over the wire with force.Following balloon removal, the guidewire was able to move freely.Under high magnification area of sheath was present and no foreign body was seen or palpable.Following reimaging and under high magnification, the broken piece of balloon was seen stuck to the stent and not moving.The guidewire was removed almost to entry site and then advanced again to be next to the stuck balloon segment.A second stent was placed in the newly placed stent to trap the broken piece in the middle part of both stents.The guidewire and sheath were removed and hemostasis was secured.The reported issue resulted in a patient delay of approximately 45 minutes.The procedure was considered to be successful after the balloon fragment was "jailed by the stent." no further medical intervention was required as the patient was in stable condition.The balloon catheter was prepped per ifu.There was no indication of device damage during preparation.The site confirmed negative pressure was held during re-introduction to the target lesion.There was no indication of negative pressure loss during re-introduction.The balloon was not torqued/twisted during re-introduction.However, the balloon burst upon being re-introduced after stent placement.There was no noted calcification present in the target vessel with a lesion length of less than 4mm.

• Brand Name: FIRST CHOICE
• 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: 20285557
• Report Number: 3005994106-2024-00015
• Device Sequence Number: 15450584
• Product Code: LIT
• UDI-Device Identifier: 08570590020075
• UDI-Public: 08570590020075
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K102645
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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 Expiration Date: 10/08/2025
• Device Model Number: UHP7594
• Device Lot Number: 22202341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 113 KG