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

Model Number	G09105
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer name and address = phone:(b)(6).G4: pma/510(k) number = 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 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 a procedure involving percutaneous transluminal angioplasty of the left anterior and posterior tibial arteries with an unspecified drug-coated balloon, a visible ¿weak spot¿/¿faulty¿ coating was noted on a roadrunner the firm hydrophilic wire guide.The anatomy was moderately stenosed, tortuous, calcified, or scarred.Access was obtained in the right femoral artery for a crossover approach.Another manufacturer¿s wire was inserted into an unknown access needle, and the needle was removed.Another manufacturer¿s 5-french sheath was placed over the wire guide.The user then attempted to exchange the wire for the complaint device; however, a rough spot was felt on the wire upon insertion.Upon removal of the wire, the user saw and felt ¿failed¿ hydrophilic coating ¿or something¿.Latex gloves were used with the wire, which was not altered prior to use.The hydrophilic coating had been activated with normal saline for one-to-two minutes and the wire was kept hydrated prior to the initial insertion attempt.The hydrophilic coating did not flake.A photo provided by the customer appears to show damage to the polymer jacket.A new device of the same type was used to 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 a procedure involving percutaneous transluminal angioplasty of the left anterior and posterior tibial arteries with an unspecified drug-coated balloon, a visible ¿weak spot¿/¿faulty¿ coating was noted on a roadrunner the firm hydrophilic wire guide.The anatomy was moderately stenosed, tortuous, calcified, or scarred.Access was obtained in the right femoral artery for a crossover approach.Another manufacturer¿s wire was inserted into an unknown access needle, and the needle was removed.Another manufacturer¿s 5-french sheath was placed over the wire guide.The user then attempted to exchange the wire for the complaint device; however, a rough spot was felt on the wire upon insertion.Upon removal of the wire, the user saw and felt ¿failed¿ hydrophilic coating ¿or something¿.Latex gloves were used with the wire, which was not altered prior to use.The hydrophilic coating had been activated with normal saline for one-to-two minutes and the wire was kept hydrated prior to the initial insertion attempt.The hydrophilic coating did not flake.A photo provided by the customer appears to show damage to the polymer jacket.A new device of the same type was used to 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.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also conducted.One used device was returned to cook for investigation.An area was damage on the wire was noted approximately 104 centimeters from the proximal end.A document-based investigation evaluation was performed.No related non-conformances were found on the complaint lot or component lot, and there have been no other reported relevant complaints for this lot number.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, 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.Based on the information provided and the results of the investigation, cook has concluded that component failure, unrelated to manufacturing or design deficiencies, contributed to this incident.It is unknown what caused the damage found on the wire guide.It is possible that other contributing factors related to the use of the device in the procedure could have led to the failure observed but this cannot be definitively determined.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ROADRUNNER THE FIRM 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: 20284148
• Report Number: 1820334-2024-01258
• Device Sequence Number: 7485214
• Product Code: DQX
• UDI-Device Identifier: 00827002091054
• UDI-Public: (01)00827002091054(17)270501(10)16038320
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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 Model Number: G09105
• Device Catalogue Number: RPC-35-260
• Device Lot Number: 16038320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: BOSTON SCIENTIFIC STARTER WIRE, BSC 5FR SHEATH.; BSC IMAGER 5FR 65CM CONTRA CATHETER.; COOK 6FR ANSEL SHEATH.
• Patient Sex: Male