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

Catalog Number CMW-14-300-25G

Device Problems Flaked (1246); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn cannot be determined.Concomitant medical products: four different cook micro guide wires were used during the procedure - g52938 (lot 9253756), g50791 (lot 8680398), g50793 (lot 9241306) and g52938 (lot 9402766).Pma/510(k) number: unavailable as the device lot number, rpn, and gpn cannot be determined.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

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.Four different cook micro guide wires were used during the procedure.Therefore, the source of the coating is unable to be determined with accuracy.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specification, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used approach cto microwire wire guide was returned for investigation.The distal tip was noted to be damage as the coils at the distal tip were elongated.A kink was noted 4.1cm from the distal tip.The ptfe coating was pealing from 93.4cm to 94.6cm from the distal tip.Additionally, peeling was noted 279cm to 283cm from the tip.A document based investigation evaluation was performed as well.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 the only other complaint associated with this lot number is connected to this same event.Furthermore, reviews of the drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.Furthermore, an ifu is provided with the device, which states ¿the wire guide should not be torqued without evidence of corresponding movement of the distal tip.Further torqueing against the resistance may cause vessel trauma or wire guide damage which may led to device fracture.Based on the information provided and the examination of the returned product, investigation has concluded that this event cannot be traced to the device but to the patient¿s anatomy.Reportedly, the patient¿s anatomy contained an obstructive lesion which could have been a contributing factor that resulted in the reported failure.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed in section h10.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.B5: upon preliminary investigation of the returned device, coil elongation was noted at the tip.A second device code has been added.Additionally, the product and lot numbers have been updated from the returned device.G2b: pro code = dqx.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

• Brand Name: APPROACH CTO MICROWIRE WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8335480
• MDR Text Key: 136887786
• Report Number: 1820334-2019-00407
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K081337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2022
• Device Catalogue Number: CMW-14-300-25G
• Device Lot Number: 9241306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/15/2019; 05/31/2019
• Supplement Dates FDA Received: 03/25/2019; 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK 5 FR 30 CM FLEXOR SHEATH