MAUDE Adverse Event Report: COOK INC ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number HPWA-35-180

Device Problem Flaked (1246)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

Product code= dqx.Concomitant products:.035 access needles, uniglide wire, short sheath, and conquest balloon.(b)(4).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 that at the end of a fistulogram with angioplasty procedure, the physician noted some of the coating of the roadrunner uniglide hydrophilic wire guide had sheared off and remnants remained in the patient's anatomy.The procedure was successfully completed.At the time of this report, the coating still remains in the patient.Per the complainant, a procedure has not been scheduled to remove the remnants.There have not been any reactions to the foreign body and the remnants seen on imaging were minimal.According to the initial reporter, the patient has not required any additional procedures nor adverse effects related to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigational findings.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that 7.5 cm(centimeter) of polymer jacket was missing starting at 14.1 cm from the distal end.A portion of the core wire was exposed.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 be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7507186
• MDR Text Key: 108092318
• Report Number: 1820334-2018-00938
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002561748
• UDI-Public: (01)00827002561748(17)201117(10)8377175
• Combination Product (y/n): N
• PMA/PMN Number: K110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: HPWA-35-180
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other