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 Code	Foreign Body In Patient (2687)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.Concomitant products= cook pedal access sheath, cook cto microwire guide, 0.014 cxc catheter, cook cxi-2.6-18-90-ang2, v-18 wire guide/ initial reporter occupation = lab manager.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
As reported, during an unknown procedure, an approach hydro st microwire wire guide separated.Access was obtained midway down the right anterior tibial artery to reach the dorsalis pedis artery.A cook cxi support catheter was used with the device.The diabetic patient's anatomy was severely calcified and the vessels were small.Resistance was encountered upon advancement of the device, and forty-five minutes into the procedure, the complaint wire guide and the catheter became "balled up".As the devices were being removed, approximately two millimeters of the wire guide separated in the patient by the anterior artery region and remains in the patient's leg.A new wire was inserted and the procedure was continued.The physician then noticed that the cxi was leaking and the device was removed, at which time the cxi was found to be cracked down the shaft.This will be reported under patient identifier (b)(6).Another cook catheter was then introduced but the lesion was unable to be crossed.The physician was able to open two vessels, but not the anterior vessels.There are no further procedures scheduled at this time.There are no plans to retrieve the separated portion of the wire guide, and the physician stated that the patient should not experience any adverse effects.
Additional Manufacturer Narrative
Event summary as reported, during an unknown procedure, an approach hydro st microwire wire guide separated.Access was obtained midway down the right anterior tibial artery to reach the dorsalis pedis artery.A cook cxi support catheter was used with the device.The diabetic patient's anatomy was severely calcified, and the vessels were small.Resistance was encountered upon advancement of the device, and forty-five minutes into the procedure, the complaint wire guide and the catheter became "balled up".As the devices were being removed, approximately two millimeters of the wire guide separated in the patient by the anterior artery region and remains in the patient's leg.A new wire was inserted, and the procedure was continued.There are no plans to retrieve the separated portion of the wire guide, and the physician stated that the patient should not experience any adverse effects.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation evaluation was thus performed.A review of the device history record was conducted.No related non-conformances were found, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the quality controls or inspection procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product is packaged with instructions for use which warn, ¿this wire guide is a delicate instrument and should be handled carefully; forceful angulation should be avoided.¿ the ifu also warns the user to advance the tip of the wire guide fluoroscopically.The wire guide should not be torqued without evidence of tip movement.Based on the information available, investigation has concluded that a the most likely cause for the event was the patient¿s reportedly severely calcified anatomy and narrow vasculature.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 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 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: 9538273
• Report Number: 1820334-2020-00017
• Device Sequence Number: 11346487
• Product Code: DQX
• UDI-Device Identifier: 00827002529397
• UDI-Public: (01)00827002529397(17)220102(10)9983494
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/18/2020

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: 01/02/2022
• Device Model Number: G52939
• Device Catalogue Number: HMW-14-300-ST
• Device Lot Number: 9983494
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 05/18/2020
• 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