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

Model Number G07937

Device Problems Flaked (1246); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address - (b)(6).Pma/510(k) # - k182985.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.

Event Description

As reported, during an angiogram, a roadrunner nimble floppy hydrophilic wire guide was sticky and got stuck in an unspecified catheter.Latex gloves were worn and the coating was activated with saline.The wire felt "ruffled" and white material was flaking off the wire, however, the user is unsure if the inner wire was exposed.The flaking was noted when flushing the wire and activation went "quickly".The device did not make patient contact.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected information: h6 (annexes a & g).Summary of event: as reported, during an angiogram, a roadrunner nimble floppy hydrophilic wire guide was sticky and got stuck in an unspecified catheter.Latex gloves were worn, and the coating was activated with saline.The wire felt "ruffled" and white material was flaking off the wire, however, the user is unsure if the inner wire was exposed.The flaking was noted when flushing the wire and activation went "quickly".The device did not make patient contact.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.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The coating was cut and shaved off, exposing the metal core.The wire was submerged in water and a gloved hand was ran across the wire.The full length of the wire felt lubricious.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.A supplier investigation was conducted.The supplier found no anomalies or non-conformances on the lot, concluding that the device was manufactured to specification.The product ifu instructs the user on how to lubricate the wire guide for use.The information provided upon review of the supplier investigation, dmr, dhr, ifu, and investigation of the returned device 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.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to the design or manufacturing of the device, contributed to this event.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.

• Brand Name: ROADRUNNER NIMBLE FLOPPY 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 Key: 16479402
• MDR Text Key: 310860408
• Report Number: 1820334-2023-00211
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002079373
• UDI-Public: (01)00827002079373(17)250912(10)14951363
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

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 Model Number: G07937
• Device Catalogue Number: RFPC-35-180
• Device Lot Number: 14951363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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