MAUDE Adverse Event Report: COOK INC SAFE-T-J FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

During the procedure to treat a patient with claudication on the left leg and a sfa occlusion with profunda stenosis on mra.A right retrograde puncture was performed and the amplatz wire guide was introduced very stiff through an 8 fr the right groin.The user was able to pass the flexor balkin guiding sheath into the vessel but only for a short distance.The procedure was completed with the catheter only being able to reach across the aortic bifurcation as the user was unable to advance the balkin sheath into the left side.The angiogram showed good right groin puncture position.Upon removing the balking sheath to replace it, the user states it was very stiff upon pulling back and the tip was reported to have separated within the patient ((b)(4) - 1820334-2017-00043).The amplatz wire guide was reported to have suffered similarly ((b)(4) - 1820334-2017-00109).All portions were successfully retrieved during the procedure.The surgeon reports the groin was very scarred.

Manufacturer Narrative

Of note, the site also reported the patient to have experienced an issue with flexor balkin guiding sheath used during the same procedure.This event was reported separately in mfr# 1820334-2017-00043.Investigation - evaluation: a review of the complaint history, documentation, instructions for use (ifu), manufacturing instructions, trends, and quality control of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record and complaint history could not be conducted.Based on the available information the root cause of the reported event cannot be conclusively determined; however, the patient's past medical history significant for claudication of the left and right leg with left sfa occlusion and profound stenosis, previous endarterectomy procedure resulting in a scarred right groin; and the user's technique/procedure may have contributed to the reported event.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.

Event Description

It was reported that during the procedure to treat a patient with claudication on the left leg and a superior femoral artery (sfa) occlusion with profound stenosis on magnetic resonance angiography (mra), a right retrograde puncture was performed and the amplatz wire guide was noted to be stiff when inserted through the eight french (8fr) via the right groin.The user was able to pass the flexor balkin guiding sheath into the vessel for only a short distance.The procedure was completed with the catheter only being able to reach the aortic bifurcation.The sheath was unable to be advanced into the left side.The angiogram showed good right groin puncture position.Upon removal of the amplatz wire guide the user reported a portion of the device to have separated within the patient.The device was successfully retrieved during an additional surgical procedure.Of note, the surgeon reported the patient's right groin to be "very scarred.".

• Brand Name: SAFE-T-J FIXED CORE WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6245506
• MDR Text Key: 64619853
• Report Number: 1820334-2017-00109
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TSCF-35-145-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Date Device Manufactured: 07/20/2016
• 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