MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX; CLIP, VASCULAR

Model Number A1603

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complaint 1 out of 12 (complaint #(b)(4)).Complaint 2 out of 12 (complaint #(b)(4)).Complaint 3 out of 12 (complaint #(b)(4)).Complaint 4 out of 12 (complaint #(b)(4)).Complaint 5 out of 12 (complaint #(b)(4)).Complaint 6 out of 12 (complaint #(b)(4)).Complaint 7 out of 12 (complaint #(b)(4)).Complaint 8 out of 12 (complaint #(b)(4)).Complaint 9 out of 12 (complaint #(b)(4)).Complaint 10 out of 12 (complaint #(b)(4)).Complaint 11 out of 12 (complaint #(b)(4)).Complaint 12 out of 12 (complaint #(b)(4)).Procedure performed: cabg - coronary artery bypass.Event description: the event date is unknown."stealth clips (x12) have not been closing once applied to blood vessel.This lack of occlusion has been causing blood vessel to have blood leakage until another stealth clip can be applied." additional information received via telephone on 31dec2019: none of the complaint clips were saved.The rep will request that the client attempt to save the product if this complaint occurs again.The clip complaints was noted over a period of time, however it is currently unclear how long this period of time was.The rep is planning to reach out to the client to determine the number of affected cases, the dates, and the procedures.Investigation for all of these stealth clips will be under investigation activity #03584.Additional information received via email on 08jan2020: "i spoke with the account contact.Because this has happened over a 3 month period and they just notified on me in december, they dont have the information of dates and specific procedures that the device malfunctioned." the three month period was clarified to be referring to october 2019 to december 2019.Additional information received via email on 13jan2020: the 12 cers were associated with model number a1603.The model number in the complaints shall be changed accordingly.Type of intervention: another stealth clip applied.Patient status: no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation, and the lot number was not provided.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.However, based on the event description and previous events that were reported to applied, it is likely that the reported event was caused by interference between the male and female jaw components.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented process enhancements intended to further minimize the potential for this type of event to occur.The event unit was manufactured prior to the implementation of the process enhancements.Recall: 2027111-01/15/20-001-r.

Event Description

Complaint 1 out of 12 (complaint #(b)(4); complaint 2 out of 12 (complaint #(b)(4); complaint 3 out of 12 (complaint #(b)(4); complaint 4 out of 12 (complaint #(b)(4); complaint 5 out of 12 (complaint #(b)(4); complaint 6 out of 12 (complaint #(b)(4); complaint 7 out of 12 (complaint #(b)(4); complaint 8 out of 12 (complaint #(b)(4); complaint 9 out of 12 (complaint #(b)(4); complaint 10 out of 12 (complaint #(b)(4); complaint 11 out of 12 (complaint #(b)(4)l complaint 12 out of 12 (complaint #(b)(4).Procedure performed: cabg ¿ coronary artery bypass "stealth clips (x12) have not been closing once applied to blood vessel.This lack of occlusion has been causing blood vessel to have blood leakage until another stealth clip can be applied." additional information received via telephone on (b)(6) 2019 from [name], applied medical.None of the complaint clips were saved.The rep will request that the client attempt to save the product if this complaint occurs again.The clip complaints was noted over a period of time, however it is currently unclear how long this period of time was.The rep is planning to reach out to the client to determine the number of affected cases, the dates, and the procedures.Additional information received via email on (b)(6) 2020 from [name], applied medical."i [name] spoke with the account contact.Because this has happened over a 3 month period and they just notified on me in december, they do t have the information of dates and specific procedures that the device malfunctioned." the three month period was clarified to be referring to (b)(6) 2019 to (b)(6) 2019.Additional information received via email on (b)(6) 2020 from [name], applied medical.The 12 cers were associated with model number.The model number in the complaints shall be changed accordingly.Patient status: no patient injury.Intervention: another stealth clip applied.

• Brand Name: A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX
• Type of Device: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9594264
• MDR Text Key: 177616413
• Report Number: 2027111-2020-00321
• Device Sequence Number: 1
• Product Code: DSS
• Combination Product (y/n): N
• PMA/PMN Number: K883909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Patient Sequence Number: 1