MAUDE Adverse Event Report: TELEFLEX MEDICAL VLOCK XLG CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE

Catalog Number 71114

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that we have had problems with vesolock gold.The small flaps in the package disconnect and can follow the clip into the patient.

Manufacturer Narrative

Qn#(b)(4).Dhr could not be performed since the lot number was not provided.The complaint sample was not returned for investigation.However, the attached photo was reviewed , and it was confirmed that that one of the "fingers" of the cartridge was broken.The reported defect was confirmed based on the photo, but the root cause cannot be established without receiving the actual sample.

Event Description

It was reported that we have had problems with vesolock gold.The small flaps in the package disconnect and can follow the clip into the patient.

• Brand Name: VLOCK XLG CLIP 6/CART 14/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8991712
• MDR Text Key: 166764767
• Report Number: 3011137372-2019-00330
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1