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

Model Number	G52939
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Loss Of Pulse (2562); Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: dqx.(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, a (b)(6) female was undergoing an angiogram with angioplasty and atherectomy.Lesion location was not specified.While the approach hydro st microwire wire guide was in the distal peroneal artery, it separated at the tip.The complaint device was coiled and while attempting to pull it back in the cook support catheter approximately two centimeters separated at the tip and was not retrieved.The procedure continued.At an unspecified point in the procedure, the patient's anterior and posterior tibial pulses were no longer registering on the doppler pulse detection device.Reportedly, the physician continued treatment and used c02 instead of contrast to take final pictures.After closing the incision, the patient's foot was blue with absent anterior and posterior tibial pulses on the doppler.The nurse massaged blood back into the foot and tissue plasminogen activator was given intravenously.A warm compress was placed on the foot.These interventions were successful in re-establishing blood flow to the foot.Upon follow up, the company representative reported it was not possible to confirm what if any contribution the tip retention had in relation to the loss of the patient's pulses.Reportedly, the physician chose not to give heparin until about an hour into the procedure which could also have had a contributory effect by disturbing the blood flow in the vessels.No additional adverse effects have been reported.Reportedly, there are no plans to retrieve the separated piece of the wire.The physician is confident that it ended up in a communicating vessel rather than a major vessel.
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, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used hmw-14-300-st-wg was returned for investigation.Kinks were noted at 63cm, 123cm, and 136cm.The overall length of the device was 297.4cm before the point of tip separation.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.Furthermore, a review of the quality control procedures, drawing, and specifications was conducted, and no gaps were discovered.Moreover, an ifu is provided with the device which states ¿the wire guide should be advanced only when visualizing the tip of the wire guide fluoroscopically.The wire guide should not be torqued without evidence of corresponding movement of the distal tip¿ it goes on to say ¿avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.¿ there is no mention of imaging for the procedure.There is no information stating that the device wasn¿t manipulating through the needle.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be traced to the device as all records indicate the device left cook¿s facility without error.Investigation has concluded that this event is likely related to the patient condition and the overall procedure as highly calcified vessels were noted.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

• 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: 8164801
• Report Number: 1820334-2018-03736
• Device Sequence Number: 1498086
• Product Code: DQX
• UDI-Device Identifier: 00827002529397
• UDI-Public: (01)00827002529397(17)210527(10)9116435
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2021
• Device Model Number: G52939
• Device Catalogue Number: HMW-14-300-ST
• Device Lot Number: 9116435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 03/14/2019
• 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
• Patient Age: 67 YR
• Patient Weight: 129