MAUDE Adverse Event Report: QUEST MEDICAL, INC SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE; VASCULAR LOOP

Model Number	1541
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue occurred outside of the us.Similar devices manufactured by quest medical are currently sold in the us.There were no patient complications resulting from this issue.An investigation will be completed and a follow up medwatch will be submitted if additional information becomes available.
Event or Problem Description
A report was received from the distributor in (b)(4).The report states that the tensioner on the saddleloop came off from the tube in two separate procedures.There were no patient complications.
Additional Manufacturer Narrative
Investigation conducted showed inconsistencies in dispensing the adhesive which holds the components of the device together.The dhr review showed the device was however within specification having been subjected to a maximum tensioner break force of >1.0 ibs without failing.Quest medical has implemented a process change as a proactive measure to prevent this issue.The process improvement involves a change in the needle size of the adhesive dispensing gauge for consistent adhesive dispensing.

• Brand Name: SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE
• Common Device Name: VASCULAR LOOP
• Manufacturer (Section D): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• MDR Report Key: 7011800
• Report Number: 1649914-2017-00088
• Device Sequence Number: 1132828
• Product Code: GAE
• UDI-Device Identifier: 20634624015412
• UDI-Public: 20634624015412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: No Information
• Device Model Number: 1541
• Device Lot Number: 0499345C01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2017
• Supplement Date Received by Manufacturer: 10/15/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1