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

Model Number 1541

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

The alleged issue occurred outside of the us.A similar device is distributed by quest medical in the us.The complaint sample is expected to be returned and an investigation will be completed when the device is received.A follow up medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding an alleged issue with the device.The report states that when the medical staff tried to use the saddleloop, the tensioner came off.Another saddleloop was used and the procedure was completed without any further issues.There were no patient complications resulting from the alleged issue.

Manufacturer Narrative

The device was evaluated and insufficient adhesive on the device was identified as the root cause of the tensioner detaching from the tape.Quest medical has implemented a process change to prevent this issue.The process improvement involves a change in the needle size of the adhesive dispensing gauge for consistent adhesive dispensing.In addition, a quality alert was raised for operator awareness.Quest will continue to monitor complaint trends for this issue.

• Brand Name: SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE
• Type of Device: VASCULAR LOOP
• Manufacturer (Section D): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• Manufacturer Contact: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 8856021
• MDR Text Key: 162885424
• Report Number: 1649914-2019-00040
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1541
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1