MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0G01, SZ 1 INSERT STEALTH FIBRA 10/BX; CLAMP, VASCULAR

Model Number	A0G01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: cardiac surgery.Event description: on (b)(6) 2024.[procedure: cardiac surgery] when it was opened, nurse noticed that the insert in question was broken.The procedure was completed with no problem by using another a0g01.Complaint sample will be returned from the hospital.Products to be returned: 1 insert.Additional information via email on 8jan2024: this insert was not actually used in the surgery because the damage was noticed when the pouch was opened.Therefore, other a0g01 was used for the surgery and it was completed with no problem.In addition, the insert did not encounter any sharp instruments during the procedure.Type of intervention: the procedure was completed with no problem by using another a0g01.Patient status: no patient involvement.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection was performed on the event unit, which confirmed that the attachment tab of the insert base was fractured.Based on the condition of the returned unit, it is likely that the fractured attachment tab occurred during the manufacturing process.It is also possible that the unit falsely passed visual inspection.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: cardiac surgery.Event description: on (b)(6) 2024 [procedure: cardiac surgery] when it was opened, nurse noticed that the insert in question was broken.The procedure was completed with no problem by using another (b)(6).Complaint sample will be returned from the hospital.Products returned: 1 insert.Additional information via email on 8jan2024: this insert was not actually used in the surgery because the damage was noticed when the pouch was opened.Therefore, other (b)(6) was used for the surgery and it was completed with no problem.In addition, the insert did not encounter any sharp instruments during the procedure.Type of intervention: the procedure was completed with no problem by using another (b)(6).Patient status: no patient involvement.

• Brand Name: A0G01, SZ 1 INSERT STEALTH FIBRA 10/BX
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18862587
• Report Number: 2027111-2024-00430
• Device Sequence Number: 16970885
• Product Code: DXC
• UDI-Device Identifier: 00607915114725
• UDI-Public: (01)00607915114725(17)270802(30)01(10)1458765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A0G01
• Device Catalogue Number: 101371301
• Device Lot Number: 1458765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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
• Patient Sex: Unknown