MAUDE Adverse Event Report: COOK ENDOSCOPY TRACER METRO DIRECT WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G26862

Device Problem Detachment Of Device Component (1104)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use states: "prior to removing wire guide from holder, flush with 30 cc of sterile water.Flush endoscope accessory channel and/or lumen of the device with sterile water then, insert wire guide floppy end first." the instructions for use advise the user: "note: for best results, wire guide should be kept wet, if applicable." if these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.The instructions for use cautions the user: "use of this wire guide with metal tip ercp devices may result in damage to the external coating and/or tip of the wire guide." the reported observation can occur if the wire guide was used with an incompatible accessory device.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

The following information was provided to cook via medwatch report mw5072361: "guidewire passed through the sphincterotome, difficult cannulation.[the] wire was removed from the sphincterotome and it was noted that the wire was sheared.It was noted on fluoroscopy that part of the wire was present in the patient.[the user] attempted to remove the wire unsuccessfully.Another guidewire was used to perform the procedure with a new sphincterotome." per the received medwatch report, states that a serious injury occurred and adverse event was checked "y".There were no other details included on the medwatch report.Multiple attempts to determine the customer or other details related to this event were completed with no results.

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Type of Device: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7001253
• MDR Text Key: 91053645
• Report Number: 1037905-2017-00672
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002268623
• UDI-Public: (01)00827002268623(17)200315(10)W3841321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2017,11/03/2017

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
• Device Operator: Health Professional
• Device Model Number: G26862
• Device Catalogue Number: METII-21-480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2017
• Distributor Facility Aware Date: 09/18/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2017
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/03/2017
• Date Device Manufactured: 03/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention