MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problems Bent (1059); Break (1069); Sticking (1597)

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a lower extremity peripheral intervention, a.035 bentson guidewire was being used but it would not advance through the entire catheter.The wire got stuck toward the distal end of the catheter.The wire guide was able to be removed from the catheter.The wire was stuck in the catheter due to the distal tip being elongated and floppy because the mandril wire broke.The wire guide also had two slight bends in between the catheter hub and the portion of the wire guide sticking out.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Product code ¿ dqx.A review of the complaint history, drawings, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used bentson wire guide was returned.The length of the wire guide is within specifications.Diameter of coil/core is within specifications.The coil is attached to the weld.The core is not attached to the weld.Bends are present at 28.0cm and 55.5cm from the proximal end.The diameter of the core is within specifications.The welds are present but the core is not attached at the distal end.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: BENTSON STRAIGHT FIXED CORE WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6547292
• MDR Text Key: 74511473
• Report Number: 1820334-2017-00901
• Device Sequence Number: 1
• Product Code: DXQ
• 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: 06/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TSFB-35-260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 DA