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

Catalog Number HPWA-35-180

Device Problem Flaked (1246)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: name and address - phone: (b)(4).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 Description

As originally reported, during a procedure involving a stenosed arteriovenous shunt in the left arm, the hydrophilic coating did not work well on two roadrunner uniglide hydrophilic wire guides.Latex gloves were worn, and the hydrophilic coating was activated for two minutes with a mixture of saline and water.The wire was then stored in a "water box".Access was obtained in the distal left upper arm and another manufacturer's 7-french sheath was inserted.The user then inserted the wet wire guide and attempted to place another manufacturer's 4-french catheter over the wire; however, insertion of the catheter over the wire was difficult.The wire was "watered again" and the catheter was rinsed.The catheter was still very difficult to push over the wire, requiring a lot of force.Per the reporter, the coating only worked to "a limited extent".The user exchanged the wire for another from the same lot; however, the same thing occurred.The user then switched to another manufacturer's wire guide and the procedure was completed, resulting in a working arteriovenous shunt.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.Upon return and initial evaluation of the devices, flaking of the hydrophilic coating was noted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5.Summary of event: as originally reported, during a procedure involving a stenosed arteriovenous shunt in the left arm, the hydrophilic coating did not work well on two roadrunner uniglide hydrophilic wire guides.Latex gloves were worn, and the hydrophilic coating was activated for two minutes with a mixture of saline and water.The wire was then stored in a "water box".Access was obtained in the distal left upper arm and another manufacturer's 7-french sheath was inserted.The user then inserted the wet wire guide and attempted to place another manufacturer's 4-french catheter over the wire; however, insertion of the catheter over the wire was difficult.The wire was "watered again" and the catheter was rinsed.The catheter was still very difficult to push over the wire, requiring a lot of force.Per the reporter, the coating only worked to "a limited extent".The user exchanged the wire for another from the same lot; however, the same thing occurred.The user then switched to another manufacturer's wire guide and the procedure was completed, resulting in a working arteriovenous shunt.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.Upon return and initial evaluation of the devices, flaking of the hydrophilic coating was noted.Additional information was received 13feb2024.The wires were used two times and the coating was reactivated before reuse.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint devices was also conducted.The complaint devices were returned to cook for investigation.The wires were not lubricious.White patches were noted prior to activation of the hydrophilic coating, confirming that the coating flaked from the wires.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional relevant complaints for this lot number.The product ifu states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿.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 devices suggests that there is evidence the devices were manufactured out of specification; however, there is no evidence of additional non-conforming devices in-house or in the field.The reported failure in this complaint is relevant to a previously open field action request; however, there was no escalation due to the lower risks associated with field complaints related to this issue, the absence of an identified systemic production problem, and the high detectability expected for this issue prior to product use.Based on the information provided and the results of the investigation, cook has concluded that a manufacturing/quality control deficiency contributed to this event.Responsible personnel were notified, and defect awareness training was completed by all responsible personnel.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

Additional information was received 13feb2024.The wires were used two times and the coating was reactivated before reuse.

• 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 Key: 18669593
• MDR Text Key: 334913601
• Report Number: 1820334-2024-00185
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPWA-35-180
• Device Lot Number: CINC003601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• 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
• Treatment: BSC 7FR SUPER SHEATH; COOK ENFORCER ASB5 10/4; SELECTIV CATHETER 4F BERN 100CM BSC IMAGER; SHUNT SET/ MERIT; STENT SINUS REPO/ OPTIMED 10/6
• Patient Age: 78 YR
• Patient Sex: Male