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

Catalog Number	HPWA-35-80
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
As reported, upon opening the packaging of a roadrunner uniglide hydrophilic wire guide, the coating was peeling off the wire guide.Another device was used to complete the unspecified procedure.The patient did not experience any adverse effects due to the occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected information: b3 additional information : b5, d9, h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 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 or Problem Description
Additional information was received 05sep2023 stating the date of the event was 14aug2023, not 15aug2023 as originally reported.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, upon opening the packaging of a roadrunner uniglide hydrophilic wire guide, the coating was peeling off the wire guide.Another device was used to complete the unspecified procedure.The patient did not experience any adverse effects due to the occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), specifications, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also conducted.The prior-to-use complaint device was returned to cook for investigation.The jacket was lifting off the wire guide, approximately nine centimeters from the distal tip.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final lot.One relevant non-conformance was noted on two devices from a sub-assembly lot; however, all affected product was scrapped, and there are 100% inspections in place to capture the non-conformance.A review of complaint history found no additional complaints for this lot number or any device containing the same sub-assembly lots as the complaint device.A search of all lots manufactured by the same personnel, during the same timeframe as the complaint device, found no relevant non-conformances or additional complaints on any of the lots.As such, cook believes this to be an isolated incident.Responsible personnel were notified.The information provided upon review of the device master record (dmr), dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured out of specification; however, cook believes this to be an isolated incident.Although one relevant non-conformance was noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.A review of the device master record (dmr) 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 quality control deficiency 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 UNIGLIDE HYDROPHILIC WIRE GUIDE
• Common Device Name: 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: 17646028
• Report Number: 1820334-2023-01168
• Device Sequence Number: 17634944
• Product Code: DQX
• UDI-Device Identifier: 00827002561724
• UDI-Public: (01)00827002561724(17)240713(10)14059956
• Combination Product (Y/N): N
• PMA/510(K) Number: K110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2024
• Device Catalogue Number: HPWA-35-80
• Device Lot Number: 14059956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 12/06/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/03/2023; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown