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

Model Number	G50790
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code: dqx wire, guide, catheter.Occupation: lead tech.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an interventional procedure of occluded left superficial femoral and popliteal arteries involving an (b)(6) year-old female, a "burr" was found on an approach cto microwire wire guide.The physician reportedly inserted the wire through another manufacturer's six french slender sheath.As the wire was removed and wiped down, a burr was felt at the area of transition between the tip and the "stiffer" part of the wire.The device was replaced with another manufacturer's guide wire for completion of the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Reviews of the complaint history, device history record, documentation, and quality control procedures and a visual inspection and functional test of the returned device were conducted during the investigation.As this device is provided by a supplier, an investigation was performed by the supplier.Visual inspection of the returned product revealed kinks 11mm and 22mm from the distal end of the device.Loose coil was also noted 22mm from the distal end.Adhered blue fibers with blood were observed 8cm from the distal end.A document-based investigation evaluation of manufacturing and inspection records performed by the supplier did not reveal any issue as it relates to the complaint.Additionally, final product complaints are reported and logged with cook.There were no other reported complaints for this lot number.Based on the information provided and the examination of the returned product, investigation has concluded that a cause for the device failure could not be determined.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 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: 8906777
• Report Number: 1820334-2019-02034
• Device Sequence Number: 2768823
• Product Code: DQX
• UDI-Device Identifier: 00827002507906
• UDI-Public: (01)00827002507906(17)221221(10)9728880
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

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: 12/21/2022
• Device Model Number: G50790
• Device Catalogue Number: CMW-14-300-6G
• Device Lot Number: 9728880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 12/31/2019
• 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: 6 FR TERUMO SLENDER SHEATH
• Patient Age: 85 YR