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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that a hiwire hydrophilic wire guide, was used during an unspecified procedure.The hiwire was inserted thru a 21g microneedle and when removing the hiwire, some of the coating came off and bunched up on the wire.A small particle of the coating was left remaining inside the patient.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient reported due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.One-1 hydro gw std an 180-018; was returned.The specimen coating appears visually and tactilely consistent.The specimen presents skived polymer jacket, with material removal, located 1.65 to 8.95cm and 11.80 to 18.5cm from the distal tip in a proximal to distal orientation, with a large radius serpentine bend located 1.50 to 14.0cm from the distal tip.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.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.There were no other reported complaints for this lot number.As noted in the instructions for use (ifu), ¿avoid manipulating or withdrawing the hydrophilic wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel.¿ based on the evidence presented by the sample and the information provided by the supporting documentation, procedural factors appear to have impacted on the event as reported.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that a hiwire hydrophilic wire guide, was used during an unspecified procedure.The access site was reported to be the left upper arm (arterial limb of av graft).The hiwire was completely soaked in saline prior to being placed in the patient.The hiwire was then inserted thru a 21g microneedle and when removing the hiwire, some of the coating came off and bunched up on the wire.A small particle of the coating was left remaining inside the patient.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient reported due to this occurrence.

• 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: 6724414
• Report Number: 1820334-2017-01635
• Device Sequence Number: 983458
• Product Code: DXQ
• UDI-Device Identifier: 00827002362772
• UDI-Public: (01)00827002362772(17)191205(10)10772075
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

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: HWA-18-180
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/15/2017
• 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: Other