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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: dqx.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A hiwire hydrophilic wire guide was used in a leg angiogram.It was reported, the wire guide was in the common femoral artery, placed through the sheath, up and over the aorta bifurcation.The patient's iliac was calcified and when trying to maneuver the wire the tip sheared off completely.They were able to get the tip into the catheter and it was removed from the patient.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation a review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), quality control data, and visual inspection of the returned product were conducted during the investigation.A gage bushing certified to be.0350¿ could not be passed over the length of the specimen due to the fracture damage and deposits of adhesive material.After wiping the specimen with a gauze pad soaked with blood-bank saline, the specimen was subjected to visual and tactile examination.The specimen coating appears visually and tactually consistent when examined at 1x ¿ 18 inches, unaided, wet.The specimen presents indications of torsional overload fracture of the polymer jacket and the metallic core wire 3.19cm from the distal tip with spiral-shaped bend damage over the distal 5cm.The polymer jacket at the fracture and distal of the fracture presents torsional deformation on the axis of the core wire.The specimen also presents deposits of adhesive material scattered over the length of the device proximal of the fracture site.Microscopically, the specimen coating appears to be worn and abraded, consistent with clinical use.Except where noted, the specimen device appears visually and dimensionally correct.The damage presented suggests the wire came into a constraint condition in the patient¿s calcified iliac and sustained the damage during manipulation to clear the wire from the calcification.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Per the instructions for use: ¿if resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the wire guide and device as a unit to prevent possible damage and/or complications." based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be determined, although the damage presented suggests the wire came into a constraint condition in the patient¿s calcified iliac and sustained the damage during manipulation to clear the wire from the calcification.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: HIWIRE HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6824469
• Report Number: 1820334-2017-02756
• Device Sequence Number: 19050670
• Product Code: DQX
• UDI-Device Identifier: 00827002362925
• UDI-Public: (01)00827002362925(17)200516(10)10841127
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HWAS-35-180
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention