MAUDE Adverse Event Report: COOK INC APPROACH HYDRO ST MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G52939
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = office manager.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
As reported, during an angiogram, an approach hydro st microwire wire guide's hydrophilic coating detached and appeared to be "frayed".Access was obtained in the groin to target the superficial femoral artery.The anatomy was not tortuous or calcified.The wire, which was not altered prior to use, was flushed with heparinized saline to activate the coating.The wire was used one time only.The coating did not flake.Another device of the same type was used to successfully complete the procedure.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.
Additional Manufacturer Narrative
Summary of event: as reported, during an angiogram, an approach hydro st microwire wire guide's hydrophilic coating detached and appeared to be "frayed".Access was obtained in the groin to target the superficial femoral artery.The anatomy was not tortuous or calcified.The wire, which was not altered prior to use, was flushed with heparinized saline to activate the coating.The wire was used one time only.The coating did not flake.Another device of the same type was used to successfully complete the procedure.The wire was not placed through a needle or metal.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.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), 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.Physical examination of the returned device revealed that the hc jacket was peeling off the wire at about 13.5 centimeters, and a kink was noted 2 centimeters from the distal tip.The kink damage was discovered when the device was returned, and the user did not mention the damage when reporting the hc jacket peeling; therefore, the damage likely occurred after the reported incident.A supplier investigation was performed by asahi intecc.The supplier investigation found no manufacturing deficiencies and concluded that the device was manufactured to specification.The supplier noted that external forces may have caused the damage; however, a definitive conclusion was not identified.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.The product ifu instructs that the wire guide is a delicate instrument and should be handled carefully and instructs that forceful angulation should be avoided.The ifu also states ¿the wire guide should be advanced only when visualizing the tip of the wire guide fluoroscopically.The wire guide should not be torqued without evidence of corresponding movement of the distal tip.Note: torquing against resistance may cause vessel trauma or wire guide damage which may lead to device fracture.¿ the ifu also cautions that excessive tightening of the torque device (if provided) onto the wire guide may result in abrasion of the coating on the wire.The information provided upon review of the complaint file, 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 manufacturing or design of the complaint device contributed to this incident.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 or Problem Description
Additional information was received 05oct2022.The wire was not placed through a needle or metal.

• Brand Name: APPROACH HYDRO ST MICROWIRE 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: 14827867
• Report Number: 1820334-2022-01115
• Device Sequence Number: 11931582
• Product Code: DQX
• UDI-Device Identifier: 00827002529397
• UDI-Public: (01)00827002529397(17)240119(10)14707158
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 01/19/2024
• Device Model Number: G52939
• Device Catalogue Number: HMW-14-300-ST
• Device Lot Number: 14707158
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK 5 X 45 SHEATH; COOK CXI 0.018 SUPPORT CATHETER
• Patient Sex: Unknown