MAUDE Adverse Event Report: COOK INC ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	RSTF-14-300
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.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, while loading another manufacturer's atherectomy device on the roadrunner extra-support bare mandril wire guide, the coating on the wire started to unravel.No kinking was noted.Reportedly, the complaint device did not make patient contact.Both the atherectomy device and the roadrunner extra-support bare mandril wire guide were removed and a new roadrunner extra-support bare mandril wire guide was used with success.No additional information has been provided.According to the complainant, the coating of the roadrunner extra-support bare mandril wire guide was activated using a heparinized saline soaked gauze.
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.A review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufactures instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the coating was absent from 7.3cm to the distal end and 4mm to the proximal end.The coating was absent at 5mm for a length of 1.4cm, at 5.3cm for a length of 3mm, at 6.0cm for a length of 1mm, at 6.4cm for a length of 1mm, and at 6.9cm for a length of 1mm.The wire guide length and diameter were both measured and found to be within specification.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, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause 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: ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7938403
• Report Number: 1820334-2018-03075
• Device Sequence Number: 16502720
• Product Code: DQX
• UDI-Device Identifier: 00827002088016
• UDI-Public: (01)00827002088016(17)230807(10)9046495
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K920824
• 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): 01/22/2019

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: No Information
• Device Expiration Date: 08/07/2023
• Device Catalogue Number: RSTF-14-300
• Device Lot Number: 9046495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 01/22/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.8 PHOENIX ATHERECTOMY DEVICE
• Patient Age: 53 YR