MAUDE Adverse Event Report: CREAGH MEDICAL SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Model Number	SRA-DC18-40220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
The device was used for balloon angioplasty of the distal superficial femoral artery (sfa).The approximate vessel diameter was 4mm with a lesion length of approximately 150mm.The estimated lesion calcification was approximately 80%.The physician experienced difficulty removing the device.Removal was performed after the initial pass by holding negative pressure on an inflation device for approximately 5-10 seconds.Deflation was not confirmed under fluoroscopy once resistance was met.The physician "tugged pretty hard" when it was noticed the balloon was not moving under fluoroscopy during withdrawal.During the removal process, the shaft separated at the rapid exchange (rx) port.The introducer sheath needed to be removed when the balloon segment was snared because the balloon did not deflate enough to pass through the sheath.All balloon segments were retrieved.After removal, the physician still needed a 6mm balloon for the proximal sfa segment.Due to removing the sheath, the physician decided to gain femoral access to treat the proximal sfa with a drug coated balloon (dcb).There was no further impact to patient outcome.The reported issue resulted in a procedure delay of approximately one hour.The reported issue may have been caused by a combination of not fully deflating the balloon and removal through high calcification.

• Brand Name: SUBLIME¿ RADIAL ACCESS 018 RX PTA 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: 17738534
• Report Number: 3005994106-2023-00006
• Device Sequence Number: 15172710
• Product Code: LIT
• UDI-Device Identifier: 05391525786308
• UDI-Public: 05391525786308
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K211044
• 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): 09/13/2023

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: 11/07/2023
• Device Model Number: SRA-DC18-40220
• Device Lot Number: 22102633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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