MAUDE Adverse Event Report: TELEFLEX MEDICAL HP APPLIER SMALL STRONGPOINT 8" CVD

Catalog Number 534150

Device Problem Separation Failure (2547)

Patient Problems Laceration(s) (1946); No Consequences Or Impact To Patient (2199)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After applying the clip, at the moment of moving the applier, the clip stuck in one of the jaws causing a 2-3mm laceration of the mammary artery.The laceration was sutured with surgical thread.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.The device history review for the alleged instrument was reviewed and found complete without any irregularities.We are unable to validate the alleged complaint at this time.The root cause is unknown.Teleflex will continue to monitor and trend related events.

• Brand Name: HP APPLIER SMALL STRONGPOINT 8" CVD
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park 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: 6979967
• MDR Text Key: 90985474
• Report Number: 3011137372-2017-00322
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 534150
• Device Lot Number: 06C1515761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• 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