MAUDE Adverse Event Report: MEDTRONIC, INC ANGIOGRAPHIC GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number 007042

Device Problem Material Distortion (2977)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It is reported that a fragment of an angiographic guide wire was trapped in a patient but was then removed.There was an unsuccessful attempt to insert a hydrophilic catheter in the patient.When the guidewire was pulled, it peeled, leaving some of the material in the patient's neck, but out of the jugular.A new procedure was necessary to remove the material from the patient.There was an exchange of the device with another brand.The material was discarded due to biological contamination.The patient suffered a temporary injury.The patient is reported as doing fine but extended hospitalization was required.

Manufacturer Narrative

The physician was attempting to place an unknown brand implantable chemotherapy catheter.The placing of the catheter was extremely difficult because the patient has significant heart enlargement on account of heart failure, as well as pacemaker on the left side.The catheter¿s accessory guide wire came with a defect, and the replacement 0.035 hydrophilic angiographic guide wire was inserted through the needle.Difficulties were encountered in moving the wire toward the atrium.The guide wire ¿hitched¿ in the needle and was damaged ¿ part of the wire¿s external material came loose and remained in the patient¿s subcutaneous tissue.The physician requested a rigid guide wire which was moved up to the atrium, via a new puncture site, and the procedure was completed successfully.The physician confirmed that the angiographic guide wire did not come with a defect but rather it was damaged during the procedure due to the difficulty encountered in the intra-surgery.

• Brand Name: ANGIOGRAPHIC GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC INC.; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5301551
• MDR Text Key: 33597531
• Report Number: 1220452-2015-00067
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082873
• 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,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 007042
• Device Lot Number: GFZF3476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 01/29/2016
• Date Device Manufactured: 06/01/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00078 YR