MAUDE Adverse Event Report: QUEST MEDICAL, INC. SADDLELOOP 18GX10CM WITH BLUNT NEEDLE; VASCULAR LOOP

Model Number	1541
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The international distributor ((b)(4)) reported an issue encountered with the saddleloop device during use.The clinician reported that the tubing was not locked into the slot of the keyhole as expected.The locking mechanism was detached from the tubing and was loose in the package.The report stated another package of the same device was used instead to complete the procedure.There were no patient complications reported as a result of the alleged issue.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Examination of the returned device confirmed the alleged complaint.The tensioner was off of the tape.Visual examination under black light found that no adhesive was present on the device.Adhesive is required to hold the tensioner on the device.The adhesive dispenser was not functioning properly, resulting in inadequate amounts of adhesive applied.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: SADDLELOOP 18GX10CM WITH BLUNT NEEDLE
• Common Device Name: VASCULAR LOOP
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6210153
• Report Number: 1649914-2016-00065
• Device Sequence Number: 16208673
• 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): 02/20/2017

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: Other
• 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: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 02/10/2017
• 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