MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MED 6/CART 180/BOX

Catalog Number 002200

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product horizon ti med 6/cart 180/box, lot number 73b1500389 investigations did not show issues related to the complaint.The device has not been returned for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the clips that were placed on a facial vein detached at the end of the surgery.More surgery was done for cervical hemorrhage.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).Eleven (11) cartridges of catalog number 002200 horizon ti med 6/cart 180/box were received not used, closed in original package, lot # 73b1500389 was confirmed with samples received, during visual inspection the cartridges are in good condition; all clips loaded properly in slots, in addition, two clips were received inside a container; clips closed.Failure mode clip slipped off vessel was confirmed with two clips (clips closed) during visual inspection.One cartridge was opened to perform a functional inspection; the testing was performed: the 4 horizon clips were loaded properly into the applier p/n 237081, batch # 06c1144840.The 4 horizon clips were released properly and no quality issues were found during inspection, then, the 4 horizon clips closed were reviewed under a microscope; clips in good condition, the 4 horizon clips were compared with the two clips received closed and it was observed the two clips are not closed completely.Based on the visual inspection of the samples "clip slipped off vessel" reported by customer was confirmed; with two closed clips, additional testing was performed to determine the root cause of failure mode.Clips available from samples other remarks: were used and a failure mode was not duplicated, 4 clips closed were compared with the two clips received (closed) and it was observed that the two clips were not fully closed according with the results the comparison.A potential cause for this defect could be the use of the device, if the clip is not fully closed in the applier, as instructed by the ifu.Therefore, no corrective action will be taken for this condition.

Event Description

Alleged event: the clips that were placed on a facial vein detached at the end of the surgery.More surgery was done for cervical hemorrhage.The patient's condition was reported as unknown.

• Brand Name: HORIZON TI MED 6/CART 180/BOX
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5233802
• MDR Text Key: 31713955
• Report Number: 3003898360-2015-00847
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 002200
• Device Lot Number: 73B1500389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention