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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC STRAIGHT EXCHANGE FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER
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COOK INC STRAIGHT EXCHANGE FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The event is currently under investigation.
 
Event Description
The area rep provided information that a straight exchange fixed core wire guide unraveled inside another manufacturer's vaccess balloon.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The visual inspection of the returned device describes one used and elongated wire guide attached to a bard conquest dilation catheter.Total length is 284.0 cm.Distal length of wire guide to catheter is 22.6 cm.Catheter is 89.3 cm.Length of wire guide proximal to catheter is 175.5 cm.Od of wire guide is.03510 inches.Wire guide starts to elongate at 127.8 cm from the proximal end.A slight bend is noted at 50.5 cm from proximal end.Only the coil penetrates the catheter.The exposed core is 3.8 cm, just proximal to the catheter.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Since this device is inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections prior to transport, it is plausible to suggest that the wire guide met with resistance beyond its intended design during the procedurally related event, possibly inadvertent contact with the bevel of the needle during insertion and/or manipulation of the wire through the needle or may have been due to patient anatomy.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
 
Event Description
The area rep provided information that a straight exchange fixed core wire guide unraveled inside another manufacturer's vaccess balloon.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
 
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Brand Name
STRAIGHT EXCHANGE 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
8128294891
MDR Report Key5865548
MDR Text Key51855077
Report Number1820334-2016-00742
Device Sequence Number1
Product Code DXQ
UDI-Device Identifier00827002006522
UDI-Public(01)00827002006522(17)210524(10)6957131
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberTSF-35-180
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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