MAUDE Adverse Event Report: COOK INC JEFFREY WIRE GUIDE EXCHANGE SET; KGZ ACCESSORIES, CATHETER

Catalog Number	JWGE-104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient was undergoing a ureteroscopy using a jeffrey wire guide exchange set.The report indicates that the "wire broke off in patients body and was removed immediately." the circumstances and handling conditions at the time of the event are not known.The anatomical site of the broken wire was not provided.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.
Event or Problem Description
Customer reported that a patient was undergoing a ureteroscopy using a jeffrey wire guide exchange set.The report indicates that the "wire broke off in patients body and was removed immediately." the circumstances and handling conditions at the time of the event are not known.The anatomical site of the broken wire was not provided.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.The customer later reported during a response to additional information that the device did not fracture, but rather unraveled about a centimeter from the tip.The unraveling of the wire occurred when the operator attempted to draw back on the wire and remove it alongside the sheath.Eventually, once the access sheath was removed, the wire was removed completely as well.The customer confirmed that the wire was discarded by the operating room staff, and as such the device is not available for analysis.
Additional Manufacturer Narrative
(b)(4).Investigation summary: a review of the complaint history, documentation, device history record, quality control and manufacturing instructions were conducted during the investigation.The device was not returned, so a detailed analysis could not be performed.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found one non-conformance; all non-conforming product was scrapped prior to further processing.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the risk assessment, no further action is required at this time.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: JEFFREY WIRE GUIDE EXCHANGE SET
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6730261
• Report Number: 1820334-2017-01541
• Device Sequence Number: 1371889
• Product Code: KGZ
• UDI-Device Identifier: 00827002044326
• UDI-Public: (01)00827002044326(17)200116(10)7594754
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: JWGE-104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 07/21/2017; 12/06/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/09/2017; 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention