MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G14731

Device Problem Fracture (1260)

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

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: patient care manager.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during an ureteral dilation procedure on a (b)(6) year old male patient using a standard fixed core wire guide the guide wire broke in half.The wire did not break in the patient, but rather upon removal.It was on the sterile tray, and when it was moved to be disposed of in the "sharps bin the one end twisted like on an elastic".The employee handling the device at this point had the skin on their finger punctured.It is noted that this is one of two wires to break this way.(reference patient identifier # (b)(6)).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and specifications.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 no other complaints associated with the complaint device lot.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 complaint device was not returned for investigation and no images or videos were provided, so a failure analysis could not be performed.There were no devices from the reported lot number remaining in stock at the distribution center to use as a representative device.The complaint was confirmed based on customer testimony.It was concluded that component failure without design or manufacturing issue contributed to the failure mode.It was reported that a third-party long taper urethral dilators and a flexible scope were used during the procedure.It is possible that compatibility issues occurred with these components.It is also possible that the wire became damaged upon insertion to the patient, or during manipulation, but was not noticed until removal.This could have been due to excessive forces, or from tortuous patient anatomy.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The appropriate internal personnel have been notified and we will continue to monitor 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

Additional information reported on the previous medical device report (mdr) was received (b)(6) 2019 not (b)(6) 2019 as reported.The additional information included that blood work was completed on the healthcare employee whose finger was punctured and will blood work will need to be repeated in september, october, and december.

Event Description

Additional information was received 12 aug 2019: the concomitant devices used during the procedure were a long taper ureteral dilator and a flexible scope.

Manufacturer Narrative

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.

• Brand Name: STANDARD FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8871651
• MDR Text Key: 153845024
• Report Number: 1820334-2019-01955
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002147317
• UDI-Public: (01)00827002147317(17)211002(10)9205666
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: G14731
• Device Catalogue Number: 638413
• Device Lot Number: 9205666
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 84