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

Catalog Number HWAS-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

Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address= address line 2: radiologie/ angiographie 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 hiwire 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 five minutes and was placed in the "watered" bowl when not in use.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 placed over the wire guide.As the user attempted to recanalize the chronic, long stenosis, the wire was difficult to advance in the vessel.The wire was removed, and the hydrophilic coating was re-activated; however, the same thing occurred.The user attempted to advance the device three-to-four times.The user denied any flaking of the wire.The user then replaced the wire with another cook wire, experiencing the same problem (reported under patient identifier (b)(6)).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 (b)(6) 2023, flaking of the wire was noted.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 hiwire 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 five minutes and was placed in the "watered" bowl when not in use.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 placed over the wire guide.As the user attempted to recanalize the chronic, long stenosis, the wire was difficult to advance in the vessel.The wire was removed, and the hydrophilic coating was re-activated; however, the same thing occurred.The user attempted to advance the device three-to-four times.The user denied any flaking of the wire.The user then replaced the wire with another cook wire, experiencing the same problem (reported under patient identifier (b)(6) (1820334-2023-00988)).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 of the complaint device was also conducted.The used complaint device was returned to cook for investigation.Some flaking/drag marks were noted on the wire guide.The device was submerged in a basin of water to activate the hydrophilic coating.Roughness was felt in several areas of the wire guide.The product ifu states ¿if movement of the wire within the device becomes diminished, remove the wire guide and reactivate the hydrophilic by wetting its entire surface with heparinized saline solution.¿ a supplier investigation was conducted.The supplier found no discrepancies on the lot and concluded that the device was manufactured to specification.The supplier concluded that a root cause could not be assigned.The information provided upon review of the dmr, supplier investigation, 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 procedural issues contributed to this event.The customer stated they used the device multiple times, rehydrating between uses.This could have possibly caused a deterioration in the hc coating/jacket material, leading to the issue.The risk analysis for this failure mode was reviewed and no additional escalation is 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: HIWIRE 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: 17425576
• MDR Text Key: 320059956
• Report Number: 1820334-2023-00987
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002362932
• UDI-Public: (01)00827002362932(17)250829(10)71002804
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K000011
• 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: 10/26/2023

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: HWAS-35-260
• Device Lot Number: 71002804
• 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: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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