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

Model Number	A1603
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9561719
• Report Number: 2027111-2020-00303
• Device Sequence Number: 19418474
• Product Code: DSS
• UDI-Device Identifier: 00607915110581
• UDI-Public: (01)00607915110581(17)240602(30)01(10)1357103
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K883909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2024
• 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
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1