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

Model Number G17542

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Internal Organ Perforation (1987)

Event Date 06/11/2019

Event Type  Injury  

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 is reported during ureteroscopy using a roadrunner nimble hydrophilic wire guide, the collecting system was perforated and contrast media extravasation occurred.It should be noted that the wire guides were being used for the first time.This happened in 4 cases.(the 3 other cases are reported in patient identifier (b)(6)).There were no additional consequences to the patient.The patient did not require any additional procedures as a result of this occurrence.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Investigation/evaluation: reviews of complaint history, device history record, documentation, drawings, specifications, and quality control data were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 found no non-conformances related to the reported failure mode.A review of complaint history records shows 3 other complaints associated with the complaint device lot, all of which were the complaints associated with this complaint.Since adequate inspection activities are in place, there have been no other reported non-conformances, and no complaints on the device lot outside of the user facility, cook has concluded that there is no evidence to suggest there is any nonconforming product in house or out in the field.The device is not supplied with specific instructions for use.The customer stated that the wire guides did not seem flexible enough, which caused perforation of the collecting system upon use.The devices were not returned for investigation, however, so there is no evidence to suggest the wire guides were not manufactured correctly.The wire guides are loaded into the spiral holder with the stiff end first.It is possible that the wires were not inserted correctly during manufacturing, causing the user to insert the stiff end into the patient first.This could have led to the perforation of the patient anatomy.It is also possible that the user removed the wire guide from the holder, and inserted the wrong end into the patient first.It is also possible that the wire guide was inserted correctly, but the user used excessive force upon insertion, leading to perforation.It is unknown what other components were used with the wire guide during the procedure, but it is also possible that another component caused the perforation, but was not observed right away.Cook has concluded that a definitive cause for the failure mode could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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: 8740004
• MDR Text Key: 149371326
• Report Number: 1820334-2019-01536
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002175426
• UDI-Public: (01)00827002175426(17)211126(10)9330687
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: G17542
• Device Catalogue Number: RFSPC-035145-0
• Device Lot Number: 9330687
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other