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

Model Number	1541
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
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.Examination of the returned device confirmed the alleged complaint.The tensioner was off of the tape.Visual examination of the device under black light found insufficient adhesive on the device.Adhesive is required to hold the tensioner on the device.A corrective action has been implemented for this issue to ensure the right amount of glue is dispensed to keep the tensioner glued to the tube.
Event or Problem Description
The foreign distributor ((b)(4)) reported an issue encountered by their customer while using the saddleloop vascular snare.The report stated that the elastic tape (tube) wasn't locked into the slot of the keyhole, and the tensioner was coming off from the tube.The report stated another package of saddleloop was opened and used to successfully complete the surgery.There were no patient complications reported as a result of the alleged issue.The device was returned to the manufacturer for evaluation.

• 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: 7011807
• Report Number: 1649914-2017-00073
• Device Sequence Number: 10884657
• 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): 11/28/2017

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: Physician
• Device Expiration Date: 10/01/2019
• Device Model Number: 1541
• Device Lot Number: 0499345C01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention