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

Model Number	G50791
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.Device evaluated by mfr: device evaluation has begun; however, a conclusion is not yet available.A total of three cook wire guides were returned which demonstrated coil elongation at the tip.Please reference the following medwatches for details: 1820334-2019-00407, 1820334-2019-00627.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
Upon preliminary investigation of the returned device, coil elongation was noted at the tip.Procedure details below: it was reported, a patient of unspecified age and gender was undergoing a below-the-knee revascularization procedure via the femoral access in an antegrade approach to the calcified posterior tibial artery.During the procedure, a cook cxi catheter was introduced over a cook micro guide wire (product and lot number unspecified).The wire coating was reportedly activated by flushing.Multiple attempts were made to cross the posterior tibial occlusion using four different cook micro guide wires.The wires passed through the catheter without any issue but did not cross the occlusion.During a subsequent attempt to cross the lesion an undetermined cook micro guide wire would not pass through the catheter.The catheter was removed and flushed outside of the patient.Something resembling a very small portion of wire coating was flushed out of the catheter (reported in medwatch 1820334-2019-00407).The procedure continued using a new catheter and the original four cook micro guide wires.These original wires passed successfully though the new catheter.The procedure was ultimately unsuccessful as the occlusion could not be crossed by any of the four cook micro guide wires due to the patient¿s anatomy.No other details were provided.Reportedly, a section of the cook micro guide wire(s) did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation reviews of the 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 package confirmed that one used wire included in the approach cto microwire wire guide was returned for investigation.The distal tip was noted to be damaged as the coils at the distal tip were elongated.Slight damage to the coating was noted near the proximal weld 95.2cm from 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 also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the specifications and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that there is no evidence to suggest that the device was at fault.Instead, investigation has drawn the conclusion to the patient¿s condition as it was reported the patient had an obstructive lesion which was likely a contributing factor to this event.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.

• Brand Name: APPROACH CTO MICROWIRE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8448404
• Report Number: 1820334-2019-00625
• Device Sequence Number: 19524421
• Product Code: DQX
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)220619(10)8680398
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: G50791
• Device Catalogue Number: CMW-14-300-12G
• Device Lot Number: 8680398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1