MAUDE Adverse Event Report: COOK INC APPROACH HYDRO ST MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	HMW-14-300-ST
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during treatment of the left peroneal artery, resistance was encountered during removal of the approach hydro st microwire wire guide.The wire guide was visualized under fluoroscopy and the tip was observed to be balled up like yarn at the end of the sheath.The physician inserted a catheter (manufacturer unspecified) in attempt to unravel the wire guide; however, the balled up tip sheared off.The catheter was used to push broken tip into the profunda so that it would not migrate.The physician then attempted retrieval of the tip with a snare (manufacturer unspecified).The tip was able to be snared, but became hooked under the patient's skin during removal, and remained within the patient's anatomy.Further retrieval has not been scheduled at this time; it is unknown as to whether retrieval will be re-attempted.Access was gained via the patient's right groin.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation a review of the dimensional verification, complaint history, device history record, documentation, drawing, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the wire was bent and frayed at the distal tip.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigational findings.

• Brand Name: APPROACH HYDRO ST MICROWIRE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7348096
• Report Number: 1820334-2018-00777
• Device Sequence Number: 13470405
• Product Code: DQX
• UDI-Device Identifier: 00827002529397
• UDI-Public: (01)00827002529397(17)200722(10)8363391
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K091385
• 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): 06/21/2018

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 Catalogue Number: HMW-14-300-ST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER(MANUFACTURER UNK),SNARE(MANUFACTURER UNK); CATHETER(MANUFACTURER UNK),SNARE(MANUFACTURER UNK)
• Outcome Attributed to Adverse Event: Other; Required Intervention