MAUDE Adverse Event Report: CREAGH MEDICAL FIRST CHOICE; PTA CATHETER

Lot Number	22200948
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device return anticipated.Follow up report with invesitgation results will be submitted.
Event or Problem Description
During a right upper arm av angioplasty procedure, a pta balloon burst during inflation.The patient was being treated for central and basilic vein stenosis of an av fistula.The balloon burst at approximately 18atm, which was the burst rate for the device.The balloon had been inflated two (2) previous times prior to the burst at 18 atm.A 2mm portion of the balloon (including distal marker) detached in vivo and migrated to the patient's right atrium of the heart.Attempts to retrieve the foreign body via vascular snare device were unsuccessful.The patient was transferred to another healthcare facility for an additional retrieval attempt.The issue may result in surgical removal of the foreign body if all endovascular attempts fail.The foreign body had not migrated any further at the moment and the patient remained in stable condition.
Additional Manufacturer Narrative
Correction: b5 updated.H3: hardware analysis confirmed the reported issue.The balloon had a longitudinal tear that traveled into the proximal balloon cone.The returned balloon also had an approximate portion of 20-25mm missing, including the already known distal tip to include the marker band (2mm) section that remained in the patient.The missing distal portion of the balloon had a section of inner tube that tapered.The outer diameter was reduced from the proximal balloon bond to the distal end of the inner tube.This narrowing was consistent with the application of a tensile force being applied, likely during withdrawal.The specification of the outer diameter is 1.24mm ±0.02mm.Three measurements taken indicated the outer diameter decreased to approximately 0.93mm at the missing section (1.01mm, 0.98mm, and 0.93mm).
Event or Problem Description
During a right upper arm av angioplasty procedure, a pta balloon burst during inflation.The patient was being treated for central and basilic vein stenosis of an av fistula.The balloon burst at approximately 18atm, which was the burst rate for the device.The balloon had been inflated two (2) previous times prior to the burst at 18 atm.A 2mm portion of the balloon (including distal marker) detached in vivo and migrated to the patient's right atrium of the heart.Attempts to retrieve the foreign body via vascular snare device were unsuccessful.The patient was transferred to another healthcare facility for an additional retrieval attempt.The issue may result in surgical removal of the foreign body if all endovascular attempts fail.The foreign body had not migrated any further at the moment and the patient remained in stable condition.Additional information received indicated the patient required open heart surgery to remove the foreign body.However, the physician was unable to locate the broken piece.The patient was stable post operatively.The balloon was prepared per requirements in the instructions for use.There was no calcification present in the vessel during the procedure.The balloon burst during the third inflation attempt.The missing portion of the catheter that was received (in access of approximately 20mm was pulled off the post procedure when the physician inspected the balloon and catheter.

• Brand Name: FIRST CHOICE
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road, balliinasloe; co. galway, ireland H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road, balliinasloe; co. galway, ireland H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: holly ramirez ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007000
• MDR Report Key: 15598977
• Report Number: 3005994106-2022-00006
• Device Sequence Number: 16726421
• Product Code: LIT
• UDI-Device Identifier: 08570590020242
• UDI-Public: 8570590020242
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 07/10/2025
• Device Lot Number: 22200948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown