MAUDE Adverse Event Report: TELEFLEX MEDICAL VCLUDE TI MED 6/CART 30/BOX; CLIP, IMPLANTABLE

Model Number IPN055281

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 01/27/2023

Event Type  Injury  

Event Description

Reported issue: we had an incident 10 days ago while doing an av fistula that a blue ligation clip was applied to the vessel and it severed the vessel causing it to retract and increased the bleeding to the arm.

Manufacturer Narrative

(b)(4).The device investigation is pending and the results will be submitted in a follow-up report.

Event Description

Reported issue: we had an incident 10 days ago while doing an av fistula that a blue ligation clip was applied to the vessel and it severed the vessel causing it to retract and increased the bleeding to the arm.

Manufacturer Narrative

(b)(4).The customer returned one cartridge of 40130 vclude ti med 6/cart 30/box and two 70462 vclude aplr med cvd 6" 152mm appliers for investigation.The cartridge and appliers were examined with and without magnification.Visual examination of the cartridge revealed obvious signs of use in the form of biological material.There were no clips remaining in the cartridge.Both appliers were misaligned.Functional inspection could not be performed on the cartridge since there were no clips remaining.However, in an attempt to simulate the reported issue, a laboratory inventory was used with the returned appliers misaligned.A clip from the laboratory inventory cartridge was able to load properly into the misaligned appliers and was able to be applied to over-stressed surgical tubing.The reported defect could not be replicated based upon the sample returned.The lot number of the finished good was not reported.However, a potential lot number was able to be identified from a review of sales history.The device history review for the potential lot number 228107 of product 40130 vclude ti med 6/cart investigation did not show issues related to complaint.A device history review of the sub-assemblies, and clips were also performed.No nonconformances or issues related to defective clips were identified.Inspection results: zero (0) defects detected during in-process and final inspections performed by qa.100% inspection of finished goods is performed by in-line inspectors.Nonconforming packages / product is required to be removed from the lot.Sub-assemblies are weight counted and variance between issuance qty and production qty did not exceed our internal variance threshold of +/-3% which would trigger an investigation.No component issues detected during sub-assembly in-process / final inspections performed by rmi quality assurance for lots 42272 or 41661.100% inspection of each cartridge assembly under magnification is performed as part of the production process.Nonconforming cartridge assemblies are required to be removed from the lot.The clip inspection showed zero visual defects /zero dimensional nonconformances detected during inspection.The ifu for this product was reviewed.Corrective action is not required at this time as the root cause could not be determined.There were no clips remaining in the returned cartridge.The customer reported complaint could not be confirmed.One cartridge and two appliers were returned.Visual examination revealed obvious signs of use in the form of biological material.There were no clips remaining in the cartridge.A dhr review was performed on the potential lot number of the returned cartridge and no relevant findings were identified.Both returned appliers were misaligned.It is possible that the misalignment of the appliers contributed to the complaint.However, without any clips returned, this could not be confirmed.The ifu for this product states "always check the alignment of applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury could occur." "appliers are precision instruments and must be handled with care.Inspect for wear or damage and confirm adequate clip pick-up prior to use.Return to vesocclude medical, llc, llc for repair as necessary.If not done a patient injury could occur." teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: VCLUDE TI MED 6/CART 30/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16496367
• MDR Text Key: 310805795
• Report Number: 3011137372-2023-00026
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704666670
• UDI-Public: 24026704666670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN055281
• Device Catalogue Number: 40130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Hospitalization; Required Intervention