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

Catalog Number HPWAS-35-260

Device Problem Flaked (1246)

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

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

E1: customer name and address= address line 2: (b)(6).Phone: (b)(6).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 balloon angioplasty with a drug-coated balloon, a physician noticed problems with the hydrophilic coating of a roadrunner uniglide hydrophilic wire guide, describing "less quality in handling, pushing, and torqueablity." the patient had a history of percutaneous transluminal angioplasty within the left superficial femoral artery (sfa), a chronic, elongated stenosis/occlusion of the left superficial femoral and proximal popliteal arteries, and placement of a stent within the external iliac artery.Latex gloves were worn.The hydrophilic coating was activated with heparinized saline for ten minutes and was placed in the "watered" bowl when not in use.The coating was reactivated before reuse.The wire was not altered prior to use.Uncomplicated access was obtained in the right femoral artery for a cross-over approach to target a chronic, long lesion within the left superficial femoral artery.A 6-french ansel sheath was used with the wire guide.As the user attempted to recanalize the chronic, long stenosis, another cook wire was difficult to advance in the vessel (reported under patient identifier (b)(6)).The wire was replaced with the roadrunner uniglide hydrophilic wire guide, which was used two-to-three times; however, the user experienced similar problems with poor thrust/force and torqueability of the wire.The user denied any flaking of the wire.Another cook wire was then used to complete the procedure, and the patient was reportedly okay.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 device on 20jul2023, flaking of the wire was noted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as originally reported, during a procedure involving balloon angioplasty with a drug-coated balloon, a physician noticed problems with the hydrophilic coating of a roadrunner uniglide hydrophilic wire guide, describing "less quality in handling, pushing, and torqueability." the patient had a history of percutaneous transluminal angioplasty within the left superficial femoral artery (sfa), a chronic, elongated stenosis/occlusion of the left superficial femoral and proximal popliteal arteries, and placement of a stent within the external iliac artery.Latex gloves were worn.The hydrophilic coating was activated with heparinized saline for ten minutes and was placed in the "watered" bowl when not in use.The coating was reactivated before reuse.The wire was not altered prior to use.Uncomplicated access was obtained in the right femoral artery for a cross-over approach to target a chronic, long lesion within the left superficial femoral artery.A 6-french ansel sheath was used with the wire guide.As the user attempted to recanalize the chronic, long stenosis, another cook wire was difficult to advance in the vessel (reported under patient identifier (b)(6) (1820334-2023-00987)).The wire was replaced with the roadrunner uniglide hydrophilic wire guide, which was used two-to-three times; however, the user experienced similar problems with poor thrust/force and torqueability of the wire.The user denied any flaking of the wire.Another cook wire was then used to complete the procedure, and the patient was reportedly okay.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 device on 20jul2023, flaking of the wire was noted.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The used complaint device was returned to cook for investigation.Some flaking was noted on the wire guide.The device was submerged in a basin of water to activate the hydrophilic coating.Roughness was felt approximately 13.5-centimeters from the curved end of the wire.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 states ¿if movement of the wire within the device becomes diminished, remove the wire guide and reactivate the hydrophilic coating by wetting its entire surface with heparinized saline solution.¿ 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.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 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.

Event Description

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

• 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: 17428183
• MDR Text Key: 320502104
• Report Number: 1820334-2023-00988
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002305069
• UDI-Public: (01)00827002305069(17)260208(10)15215103
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130766
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPWAS-35-260
• Device Lot Number: 15215103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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: COOK 6-FR KCFW ANSEL; DCB MEDTRONIC INPACT ADMIRAL 5/40; STERLING 3/150 BSC, MUSTANG 5/200 BSC; VERT 4-FR CATHETER BSC, STARCLOSE ABBOTT
• Patient Age: 60 YR
• Patient Sex: Female