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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

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COOK INC ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER Back to Search Results
Catalog Number HPWA-35-260
Device Problem Flaked (1246)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
As originally reported, during an unknown procedure(s), four roadrunner uniglide hydrophilic wire guides were "sticky and tacky", even when kept wet in a basin of sterile water when not in use.The wires were attempted to be advanced through a cook catheter; however, resistance was felt and the wires became "impossible to pass".Upon removal of the wires, the user was concerned that the coating would "shear off"; however, there was no report any shearing separation of the coating.Per the reporter, the "sticky and tacky" feeling was felt with any device tracked over these wires.The wires were removed, and a competitor's wire was used for the procedure(s).A section of the device did not remain inside any patient's body.The patient(s) did not experience any adverse effects or require any additional procedures due to these occurrences.Additional information was received 11mar2024, stating that "clear gelatinous and sometimes powdery" material flaked from the wires; however, the metal was not exposed.Both latex and powdered gloves were worn, and the coating was initially activated with heparinized saline.The wires were used immediately after activation and were used one time.
 
Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as originally reported, during an unknown procedure(s), four road runner uniglide hydrophilic wire guides were "sticky and tacky", even when kept wet in a basin of sterile water when not in use.The wires were attempted to be advanced through a cook catheter; however, resistance was felt and the wires became "impossible to pass".Upon removal of the wires, the user was concerned that the coating would "shear off"; however, there was no report any shearing/separation of the coating.Per the reporter, the "sticky and tacky" feeling was felt with any device tracked over these wires.The wires were removed, and a competitor's wire was used for the procedure(s).A section of the device did not remain inside any patient's body.The patient(s) did not experience any adverse effects or require any additional procedures due to these occurrences.Additional information was received 11 mar 2024, stating that "clear gelatinous and sometimes powdery" material flaked from the wires; however, the metal was not exposed.Both latex and powdered gloves were worn, and the coating was initially activated with heparinized saline.The wires were used immediately after activation and were used one time.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.The complaint device(s) were not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record for the complaint lot and subassembly lots found no relevant non-conformances.A review of complaint history found one additional relevant complaint for this lot number for the same failure mode.The customer followed all relevant instructions in the ifu related to this failure.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and ifu, suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this incident.The exact conditions experienced during the event cannot be duplicated.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
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Brand Name
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
Type of Device
DQX WIRE, GUIDE, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC.
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key19042119
MDR Text Key339443232
Report Number1820334-2024-00464
Device Sequence Number1
Product Code DQX
UDI-Device Identifier00827002304925
UDI-Public(01)00827002304925(17)261024(10)15721427
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHPWA-35-260
Device Lot Number15721427
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received04/04/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
.035 CXI
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