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

Model Number	G30506
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code: dqx wire, guide, catheter.(b)(6).Occupation: lab manager.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
As reported, during an unknown procedure, the coating of a roadrunner uniglide hydrophilic wire guide came off the wire, leaving the bare wire visible to the user.The wire was replaced to complete the procedure.There has been no report that a section of the device remained inside the patient¿s body, that the patient required any additional procedures due to this occurrence, or that the patient experienced any adverse effects due to this occurrence.Additional information regarding the event and patient outcome have been requested.
Event or Problem Description
Additional information received (b)(6) 2020.As reported, the device was used during a peripheral leg intervention via right common femoral artery access.The patient's anatomy was calcified but not tortuous.The device was handled using non-latex powder-free gloves, activated in a "standard fashion", and flushed with heparinized saline prior to insertion.The device was removed from the patient and reinserted twice and kept in heparinized saline between uses.Following the third removal of the device from the patient, a black colored material was observed flaking from the device.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D11: concomitant products= cook 6 french ansel sheath, cook rim angiographic catheter, cook 4.0 french 135cm cxi angled catheter.H3: device evaluated by mfg = other (81) - 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.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.
Additional Manufacturer Narrative
Summary of event: as reported, during an unknown procedure, the coating of a roadrunner uniglide hydrophilic wire guide came off the wire, leaving the bare wire visible to the user.The wire was replaced to complete the procedure.Additional information received 23jun2020.As reported, the device was used during a peripheral leg intervention via right common femoral artery access.The patient's anatomy was calcified but not tortuous.The device was handled using non-latex powder-free gloves, activated in a "standard fashion", and flushed with heparinized saline prior to insertion.The device was removed from the patient and reinserted twice and kept in heparinized saline between uses.Following the third removal of the device from the patient, a black colored material was observed flaking from the device.There has been no report that a section of the device remained inside the patient¿s body, that the patient required any additional procedures due to this occurrence, or that the patient experienced any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Inspection found a 10cm section of exposed mandril wire starting at 98.5cm from the distal tip.The sheared jacket section was not returned.No other issues were identified during the analysis.A document-based investigation evaluation was performed.A total of six possibly related non-conformances were noted on subassembly lots; however, all devices were scrapped.No non-conformances were noted on the final lot.There have been no other reported complaints for this lot number.Given that there are no related complaints on this lot and all non-conforming subassembly units were identified and scrapped accordingly, there is objective evidence to support that the device was manufactured to specification.Cook also reviewed the device master record as it pertains to the reported failure mode.Current risk controls include design verification and validation testing, process validation testing, the product ifu and 100% qc inspection prior to shipping.Cook has confirmed that there are adequate controls in place to mitigate the risk of this failure mode.The product ifu provides instruction for activation of the hydrophilic coating.Based on the information provided and the results of the investigation, cook has concluded that a definitive cause for this complaint could not be established.Possible causes for this event include patient anatomy and procedural issues.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.
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: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10091863
• Report Number: 1820334-2020-00990
• Device Sequence Number: 14223739
• Product Code: DQX
• UDI-Device Identifier: 00827002305069
• UDI-Public: (01)00827002305069(17)221226(10)10207204
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K130766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2021

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: 12/26/2022
• Device Model Number: G30506
• Device Catalogue Number: HPWAS-35-260
• Device Lot Number: 10207204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/23/2020; 01/11/2021
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/29/2020; 01/14/2021
• 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: SEE H10