MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER SMALL WIDE 8" CVD; APPLIER, SURGICAL, CLIP

Catalog Number 137082

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medwatch report number: mw5070873.The facility has communicated that the device is not available for evaluation.Teleflex will continue to monitor and trend related events.

Event Description

While harvesting the left internal mammary artery (lima), the surgeon noted that the small clip appliers were not functioning properly.The scrub passed the other clip applier to the surgeon which he used and noted were also not applying the clips properly, resulting in a branch of the lima being transected, damaging the vessel.This course of events led to the surgeon harvesting the right mammary artery (rima), lengthening the procedure time and placing the patient at further risk (diminished blood flow to chest wall).The clip appliers were removed from the field and automatic clip appliers were utilized for the remainder of the case.The patient's condition is unknown at this time.

Manufacturer Narrative

(b)(4).Since this instrument was not returned and lot information has not been provided, we are unable to perform a thorough dhr review at this time.Since the instrument was not returned for evaluation we are unable to validate this complaint or determine root cause at this time.All instruments are thoroughly inspected and function tested at time of manufacture.

Event Description

While harvesting the left internal mammary artery (lima), the surgeon noted that the small clip appliers were not functioning properly.The scrub passed the other clip applier to the surgeon which he used and noted were also not applying the clips properly, resulting in a branch of the lima being transected, damaging the vessel.This course of events led to the surgeon harvesting the right mammary artery (rima), lengthening the procedure time and placing the patient at further risk (diminished blood flow to chest wall).The clip appliers were removed from the field and automatic clip appliers were utilized for the remainder of the case.The patient's condition is unknown at this time.

• Brand Name: HZ APPLIER SMALL WIDE 8" CVD
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6785584
• MDR Text Key: 82400894
• Report Number: 3011137372-2017-00255
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 137082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention