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

Model Number	SRA-DC14-35150
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the returned balloon catheter confirmed a puncture just distal to the proximal marker band.Fluid was able to be passed through the inner lumen with the use of an inflation device and out the puncture location.Necking was visible at the balloon and catheter shaft bond.
Event or Problem Description
The balloon was used during an atherectomy procedure through the left radial artery.The physician performed and angiogram with distal superficial femoral artery (sfa) atherectomy using a competitor's laser catheter technology.Upon conclusion of that therapy, the balloon was used.The balloon was delivered to the target lesion and inflated without issue.During removal, the balloon could not be deflated.Several techniques were attempted without resolution.The physician decided to use a 21g needle to pop the balloon and remove.The issue occurred after the initial inflation that intended to be inflated for approximately 30 seconds.The balloon was inflated to 6atm.The tortuosity was reported as normal.Troubleshooting include multiple deflation attempts with the inflator, manual pull back with a syringe on side, and manual pull back direct from the balloon.The physician also inserted a guidewire through the balloon and applying manual pressure to the outside of the patient's leg to pop.The reported issue resulted in a procedure delay of approximately 25 minutes.There was no further patient harm.There was no further patient harm reported.

• 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): SURMODICS INC; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525077598
• MDR Report Key: 18927266
• Report Number: 3005994106-2024-00003
• Device Sequence Number: 15814027
• Product Code: LIT
• UDI-Device Identifier: 05391525783888
• UDI-Public: 05391525783888
• 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): 03/18/2024

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: 07/27/2024
• Device Model Number: SRA-DC14-35150
• Device Lot Number: 22201521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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: 68 YR
• Patient Sex: Female