MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A1611, 6MM L/L 1/2 F SPRING CLIP 10/BX; CLIP, VASCULAR

Model Number A1611

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The event unit will not be returning to applied medical for evaluation.However (b)(4) sterile units are anticipated to return.A follow-up report will be submitted upon completion of investigation.

Event Description

Procedure performed: cabg.Event description: when trying to put a clamp on the ima the clamp broke.All pieces were removed from the patient, there was no patient injury.It is unknown how the case was completed.The event unit is not returning.The remaining sterile units from the same box will be returning.Additional information was received via email on (b)(6) 2022 from health system manager rep has been unable to get any information.Rep should be able to find out how many products will be returned.Additional information was received via email on (b)(6) 2022 from health system manager there are (b)(4) sterile units being returned.Patient status: no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medial for evaluation.However, thirty-six (36) representative sterile units were returned.Testing was performed on the representative sterile units.All representative sterile units met current specifications and there were no visible non-conformances.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: cabg.Event description: when trying to put a clamp on the ima the clamp broke.All pieces were removed from the patient, there was no patient injury.It is unknown how the case was completed.The event unit is not returning.The remaining sterile units from the same box will be returning.Additional information was received via email on 30aug2022 from health system manager rep has been unable to get any information.Rep should be able to find out how many products will be returned.Additional information was received via email on 07sep2022 from health system manager there are 36 sterile units being returned.Patient status: no patient injury.

• Brand Name: A1611, 6MM L/L 1/2 F SPRING CLIP 10/BX
• Type of Device: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15463279
• MDR Text Key: 302189617
• Report Number: 2027111-2022-00737
• Device Sequence Number: 1
• Product Code: DSS
• UDI-Device Identifier: 00607915110598
• UDI-Public: (01)00607915110598(17)270501(30)01(10)1447702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1611
• Device Catalogue Number: 101374301
• Device Lot Number: 1447702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1