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 Date 12/18/2019

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) - clip 1.Complaint 2 of 2: (b)(4) - clip 2.Name of procedure: heart procedure.Limited information available at the time of the report.In the middle of the procedure they were trying to place 2 stealth spring clips and they would not stay closed.These clips were removed.They pulled 2 more clips from another lot number, these did stay closed and case completed.There was no damage to the vessel.There was no loss of occlusion due to the clips not staying closed.The clips are available for return.Intervention: replaced with new clip of a different lot number.Patient status: no patient injury.

Event Description

Complaint 1 of 2: (b)(4) - clip 1.Complaint 2 of 2: (b)(4) - clip 2.Procedure performed: heart procedure.Limited information available at the time of the report.In the middle of the procedure they were trying to place 2 stealth spring clips and they would not stay closed.These clips were removed.They pulled 2 more clips from another lot number, these did stay closed and case completed.There was no damage to the vessel.There was no loss of occlusion due to the clips not staying closed.The clips are available for return.Intervention: replaced with new clip of a different lot number.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, along with representative sterile units.Testing was performed on the event unit, which confirmed that the clip was not able to close.The sterile units were also tested and non-conformances were observed.Based on the condition of the returned unit, 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 is currently researching possible process and inspection enhancements intended to further minimize the potential for this type of event to occur.Recall: 2027111-01/15/20-001-r.

• 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: 9561719
• MDR Text Key: 177625598
• Report Number: 2027111-2020-00303
• Device Sequence Number: 1
• Product Code: DSS
• UDI-Device Identifier: 00607915110581
• UDI-Public: (01)00607915110581(17)240602(30)01(10)1357103
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1603
• Device Catalogue Number: 101374101
• Device Lot Number: 1357103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1