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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode = dqx.Device evaluated by mfr: device evaluation has begun; however, a conclusion is not yet available.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) male was undergoing an angioplasty procedure of the anterior tibial artery via groin access site.During advancement of a crosscath support catheter (reported in medwatch 1820334-2019-00606), a cook cto microwire wire guide was observed to come out of a hole different than the tip of the catheter, and advanced into a side branch.Patient anatomy was described as tortuous and calcified but not extremely so.Another crosscath support catheter was placed and the procedure was successfully completed without any adverse effect to the patient.No other procedures were required.A cook approach cto microwire wire guide, lot number 9274374 was returned with the crosscath support catheter described above.Upon preliminary visual review of the wire guide, it was noted the coils at the distal end of the wire were elongated.This report captures the coil elongation on the wire guide.The investigation is on-going.
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, drawing, instructions for use (ifu), manufacturer¿s instructions, 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 approach cto microwire wire guide was returned to cook for investigation.The device was found to be elongated.The elongation was noted to be 3mm in length and was 3.63cm 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 manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states "this wire guide is a delicate instrument and should be handled carefully; forceful angulation should be avoided." it goes on to say "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." based on the information provided and the examination of the returned product, investigation has concluded a root cause for this event could not be established.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: 8459758
• Report Number: 1820334-2019-00721
• Device Sequence Number: 16624866
• Product Code: DQX
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)221201(10)9274374
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: 12/01/2022
• Device Model Number: G50791
• Device Catalogue Number: CMW-14-300-12G
• Device Lot Number: 9274374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: PREVIOUSLY STATED
• Patient Age: 71 YR