MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MED 6/CART 180/BOX; CLIP, IMPLANTABLE

Model Number IPN914925

Device Problems Failure to Form Staple (2579); Lack of Effect (4065)

Patient Problem Exsanguination (1841)

Event Date 05/15/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Part number 002200 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 59 samples were taken from the current production, the samples were functionally inspected, and during the test issue reported "ligation failure-clip reopened" was not observed in the current manufacturing process.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The report states "total thyroidectomy completed on patient.Patient transferred over to stretcher.Drain noted to be full, and patient's neck noted to be swelling.Patient transferred back onto or bed and surgical incision reopened.Surgeon noted that titanium clip had come off of vessel and was bleeding.Upon further examination surgeon noted that several (7) of the clips had come off".As a result, a procedure to properly close the surgical incision was performed.The patient status is reported as "stable".Associated to mdr 3003898360-2023-00820 for a different lot number used.Additional information requested regarding total cartridges used.At time of this report, no additional information has been received by complainant.

Manufacturer Narrative

(b)(4).Additional information received 30-may-2023 from the ent physician and the rn care facilitator at the user facility.It was confirmed that 7 clips came off the vessel.It was reported that "pt had bleeding in the mecknupon extubation that was identified immediately.He was put back under ga.Wound opened, clit evacuated, site if bleeding identified as superior thyroid artery (clips had been sued at this site during the surgery), bleeding controlled, wound closed.Pt extubated and brought to recovery room in good condition.No long term problems." it was also reported that "pt required the surgery to evacuate the hematoma and control the bleeding.Los was not affected (he was already being admitted sda).".

Event Description

The report states "total thyroidectomy completed on patient.Patient transferred over to stretcher.Drain noted to be full, and patient's neck noted to be swelling.Patient transferred back onto or bed and surgical incision reopened.Surgeon noted that titanium clip had come off of vessel and was bleeding.Upon further examination surgeon noted that several (7) of the clips had come off".As a result, a procedure to properly close the surgical incision was performed.The patient status is reported as "stable".Associated to mdr 3003898360-2023-00820 for a different lot number used.

• Brand Name: HORIZON TI MED 6/CART 180/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16988955
• MDR Text Key: 315829434
• Report Number: 3003898360-2023-00811
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704696363
• UDI-Public: 24026704696363
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN914925
• Device Catalogue Number: 002200
• Device Lot Number: 73L2200903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.