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

Model Number G18154

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

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 during a ureteroscopy, a roadrunner the firm hydrophilic wire guide was used.While moving the guide wire within the working channel of the scope the physician felt resistance and the coating of the guide wire appeared to be flaking off.It is unknown how the procedure was completed.It was reported that the patient did not experience any adverse effects due to this occurrence.No section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.Additional information has been requested and will be included in a follow-up report when/if that information is received.

Event Description

Additional information was received 21nov2019: it was reported, the hydrophilic coating and a slight amount of the polymer jacket was what appeared to be flaking off.A new guide wire was opened to replace the existing guide wire to complete the procedure.

Manufacturer Narrative

Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.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.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported that the coating on a rpc-035145 (roadrunner the firm hydrophilic wire guide) was "flaking off" during a ureteroscopy on (b)(6) 2019.The wire guide was being manipulated through a kar storz ureteroscope (unknown catalog number), and the customer noted resistance while moving the wire guide through the scope.A new wire guide was used to complete the procedure and the patient did not experience adverse effects.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, and quality control data.The customer returned one used rpc wire.There was no visible biological matter.The white polymer jacket was damaged at 12.5cm from the distal end of the guide.The damage was 5.7cm in length.The jacket appeared to have been scraped away in this section.There was no additional damage on the device.A review of the device history record (dhr) found relevant nonconformances for "surface defect" and "inadequate tip".All of these nonconforming devices were scrapped.Although there were applicable nonconformances in the wire guide subassembly, this device is 100% visually inspected for this failure.Therefore, cook concluded there are appropriate controls in place to detect this failure.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The customer did not provide catalog information for the karl storz ureteroscope, so cook cannot confirm if the roadrunner wire guide was compatible with this concomitant device.Base don the device history record review, here is no evidence the device was nonconforming.Cook concluded the cause of this event is component failure without design or manufacturing 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.

Event Description

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

• Brand Name: ROADRUNNER THE FIRM 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: 9354679
• MDR Text Key: 177637330
• Report Number: 1820334-2019-02934
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002181540
• UDI-Public: (01)00827002181540(17)220529(10)9771420
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2020

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: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: G18154
• Device Catalogue Number: RPC-035145
• Device Lot Number: 9771420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/21/2019; 04/16/2020
• Supplement Dates FDA Received: 12/12/2019; 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KARL STORZ URETEROSCOPE