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

Model Number	EUHP75164
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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
During an angioplasty procedure, a balloon catheter was used and would not deflate.The patient was sent to the hospital to resolve the issue.The fistula was located in the patient's arm in the subclavian vein.The level of vessel calcification and lesion length were unknown.The degree of stenosis was approximately 50%.The balloon was inflated to 14psi and prepped per ifu requirements.The reported issue occurred during initial inflation.The patient was noted to be larger and the physician was unable to locate the exact area confidently with ultrasound to deflate the balloon.The physician thought it would be better for the patient to get to care where they could receive a ct scan.The balloon was ruptured at the hospital without issue and the patient received dialysis via access.The patient was reported to be doing well.The patient then came back to the site on (b)(6) 2023 for additional intervention on the access.The second procedure was completed without issue.There was no further impact to the patient.

• 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: 17165762
• Report Number: 3005994106-2023-00002
• Device Sequence Number: 5386226
• Product Code: LIT
• UDI-Device Identifier: 08570590020235
• UDI-Public: 08570590020235
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

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
• Device Expiration Date: 09/04/2025
• Device Model Number: EUHP75164
• Device Lot Number: 22200539
• 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: 05/24/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 173 KG