MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX; CLIP, VASCULAR

Model Number A1602

Device Problem Difficult to Open or Close (2921)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit will not be returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

Procedure performed: bypass surgery.Event description: ai translation: i would like to come back to you about a quality problem concerning the reference mentioned in the subject and for which a procedure is in progress.The bulldogs were used during interventions at the time of my predecessor and would have visibly experienced problems in two forms: slow return of the jaws from the clip imperfect closing pressure of the jaws with fluid leakage during installation.The same phenomenon occurred last monday, during a bypass surgery.The practitioner showed me the leakage while the clip was in place.However, i could see that our products were either pre-positioned on an applicator for a period of time varying from 27 mn to 41 mn while waiting for their use, or placed astride the edges of the cups.I am attaching the photos so that you can appreciate the positioning of the clips with their use.I am not an expert in metallurgy, but it seems to me that the ability of metals to regain their initial position and shape depends on the forces applied and the time during which these forces are applied in stretching.Additional information received from applied medical representative via product complaint form (b)(6) 2023: the clips are either positioned on the applicator and remain in the open position between 15 minutes and 40 minutes, or they are also placed in the closed position on the edge of the cups.When applying the clip to the vessel, the desired hemostasis is not achieved, and little bleeding is visible.No sequelae are noted for the patient.Only the surgeon is involved during the procedure, because hemostasis is imperfect.The clip has been replaced with an other after a conversation new one.No other instruments were used when the complaint event occurred.Additional information received from applied medical representative via email (b)(6) 2023: the operating room teams got rid of the packaging.All the information concerning the batch number is missing.Additional information received from applied medical representative via email (b)(6) 2023: the incident took place on (b)(6).The territory manager was present on the case.Type of intervention: the clip has been replaced with another new one.Patient status: no sequelae are noted for the patient.Only the surgeon is involved during the procedure, because hemostasis is imperfect.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.Testing was performed to replicate the complainant¿s experience with five (5) representative units.However, all five (5) representative units functioned as intended after remaining in the open position for an extended period of time.As the event unit was not returned, applied medical is unable to determine if the event exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the 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: bypass surgery event description: ai translation: i would like to come back to you about a quality problem concerning the reference mentioned in the subject and for which a procedure is in progress.The bulldogs were used during interventions at the time of my predecessor and would have visibly experienced problems in two forms: slow return of the jaws from the clip imperfect closing pressure of the jaws with fluid leakage during installation.The same phenomenon occurred last monday, during a bypass surgery.The practitioner showed me the leakage while the clip was in place.However, i could see that our products were either pre-positioned on an applicator for a period of time varying from 27 mn to 41 mn while waiting for their use, or placed astride the edges of the cups.I am attaching the photos so that you can appreciate the positioning of the clips with their use.I am not an expert in metallurgy, but it seems to me that the ability of metals to regain their initial position and shape depends on the forces applied and the time during which these forces are applied in stretching.Additional information received from applied medical representative via product complaint form 28mar23: the clips are either positioned on the applicator and remain in the open position between 15 minutes and 40 minutes, or they are also placed in the closed position on the edge of the cups.When applying the clip to the vessel, the desired hemostasis is not achieved, and little bleeding is visible.No sequelae are noted for the patient.Only the surgeon is involved during the procedure, because hemostasis is imperfect.The clip has been replaced with an other after a conversation new one.No other instruments were used when the complaint event occurred.Additional information received from applied medical representative via email 28mar23: the operating room teams got rid of the packaging.All the information concerning the batch number is missing.Additional information received from applied medical representative via email 30mar23: the incident took place on monday, the 20th.The territory manager was present on the case.Type of intervention: the clip has been replaced with another new one.Patient status: no sequelae are noted for the patient.Only the surgeon is involved during the procedure, because hemostasis is imperfect.

• Brand Name: A1602, 6MM L/L STEALTH CLIP 1/4 F 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: 16683014
• MDR Text Key: 312705795
• Report Number: 2027111-2023-00407
• Device Sequence Number: 1
• Product Code: DSS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K883909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CLIP APPLICATOR.