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 Defective Component (2292)

Patient Problem Not Applicable (3189)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.

Event Description

Complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Procedure performed: cardiac surgery.On (b)(6) 2020: during a preparation for procedure.Occurred during a pre-use inspection.S-clip did not close.Because we used other products the procedure was completed with no problem.The lot returning is unknown.[distributor] provided these 2 possible lots: lot # 1354137 or 1365527.Intervention: used other products to complete procedure.Patient status: na.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed that the clip did not close.Based on the condition of the returned unit, it is likely that the reported event was caused by interference between the male and female jaw components.The probability and criticality of harm resulting from this failure have been evaluated and were found to be unacceptable.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.Recall: 2027111-01/15/20-001-r.

Event Description

Complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Hospital: [name].On february 10, 2020: during a preparation for procedure.Occurred during a pre-use inspection.S-clip did not close.Because we used other products the procedure was completed with no problem.Comments from [distributor]: complaint sample was returned from the hospital.The sample will be returned to applied medical.The lot returning is unknown.[distributor] provided these 2 possible lots: lot # 1354137 or 1365527.

• 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
• MDR Report Key: 9795925
• MDR Text Key: 182287626
• Report Number: 2027111-2020-00407
• 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: distributor,foreign,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1602
• Device Catalogue Number: 101374001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2020
• Patient Sequence Number: 1