MAUDE Adverse Event Report: CREAGH MEDICAL SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Model Number	SRA-DC14-20100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon catheter was used in a percutaneous transluminal angioplasty (pta) procedure with left common femoral artery (cfa) access.The target vessel was the posterior tibial artery.The balloon catheter was used to finish the procedure.It was noted the target vessel was highly calcified.There was no report of resistance being encountered during advancement/removal.The physician was a high volume provider and confirmed deflation prior to removal.During removal, the catheter shaft separated in the mid to distal portion of the shaft.The distal segment could not be retrieved following several hours of effort.Due to the length of the catheter outside of the patient, the remaining catheter was kept straight or in large loops.The physician stated the midshaft joint was retained in the patient popliteal artery during the procedure.The patient was transferred to a hospital and placed on heparin overnight.The next morning, an additional open and cut-down procedure was performed to surgically remove the distal segment.The balloon portion of the catheter was still connected to the shaft.No further catheter segments remained.There was no further patient harm.
Additional Manufacturer Narrative
H3: analysis of the returned balloon catheter confirmed the reported issue.Only the proximal segment was returned.There was a ductile failure at the mid-shaft bond of the distal subassembly and the proximal jacket.The cause of the fracture could not be determined with the information provided.The site reported high vessel calcification, but did not report any resistance during insertional/removal.

• Brand Name: SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER
• 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: 19280215
• Report Number: 3005994106-2024-00005
• Device Sequence Number: 7659451
• Product Code: LIT
• UDI-Device Identifier: 05391525783666
• UDI-Public: 05391525783666
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K200700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 07/03/2024
• Device Model Number: SRA-DC14-20100
• Device Lot Number: 22201593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 76 KG