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

Catalog Number 534150

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An applier that was used on a mammary vessel during a coronary artery bypass graft cut the vessel, causing the patient to return for another procedure to seal the vessel that evening and the patient was moved to cv icu.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Dhr for the instrument in question, was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) as part of a 49 pc.Lot in february of 2016.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 visually inspected and function tested at time of manufacture.No corrective action required at this time.

Event Description

An applier that was used on a mammary vessel during a coronary artery bypass graft cut the vessel, causing the patient to return for another procedure to seal the vessel that evening and the patient was moved to cv icu.The patient's condition was reported as fine.

• Brand Name: HP APPLIER SMALL STRONGPOINT 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: 6387791
• MDR Text Key: 69375841
• Report Number: 3011137372-2017-00045
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 534150
• Device Lot Number: 06CI516946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• 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