MAUDE Adverse Event Report: COOK INC ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G17542

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: other non-healthcare professional: analyst.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported on 23jan2020 that prior to a ureterolithotrisy and double j stent implant, a roadrunner nimble hydrophilic wire guide could not be removed from the protective sheath and did not make patient contact.Another wire guide was used to complete the procedure.Upon return of the device from the customer for investigation, 26feb2020, it was discovered that the wire guide had broken or separated within the holder.It was reported that the patient did not experience any adverse effects due to this occurrence.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Investigation ¿ evaluation.Cook was informed on 23jan2020 of an incident involving a roadrunner nimble hydrophilic wire guide.On (b)(6) 2019 prior to a ureterolithotrisy and double j implant procedure the wire guide got stuck inside the protective sheath.Another wire guide was opened.There were no adverse effects to the patient as a result of this incident.A visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, manufacturing instructions, specifications, and quality control data.Upon return of the device it was found that the wire guide had broken within the holder and coating was missing.The complainant returned one damaged wire guide in a wire guide holder to cook for investigation.Physical examination of the returned device showed the wire guide was stuck in the holder.Liquid droplets were noted in the holder.The wire was broken.Approximately 5cm of white coating was missing from the distal end.The mandril and safety wire were exposed.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.From the returned device, it appears the wire guide adhered to the inner diameter of the wire guide holder.It is possible the wire was not sufficiently coated or temperature dependent environmental storage conditions affected the coating causing the wire guide to adhere to the wire guide holder.The wire guide was returned broken within the holder and part of the polymer jacket coating missing.This damage most likely occurred as an effect of the wire guide being stuck.It is possible the user tried to pull the wire guide out with forceps which can pull the polymer jacket off and damage the wire.The investigation conclusion for this complaint is cause traced to a component failure without a manufacturing or design deficiency.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 NIMBLE HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9768603
• MDR Text Key: 181954088
• Report Number: 1820334-2020-00492
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002175426
• UDI-Public: (01)00827002175426(17)220116(10)9450440
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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: No Information
• Device Expiration Date: 01/16/2022
• Device Model Number: G17542
• Device Catalogue Number: RFSPC-035145-0
• Device Lot Number: 9450440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1