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

Catalog Number METII-21-480

Device Problems Peeled/Delaminated (1454); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: boston scientific 5-4-3 tip style contour ercp cannula.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.The wire guide was returned in the wire guide holder.The wire guide holder appears to have been flushed with saline/water.The coil spring is still attached to the distal end of the wire guide.Approximately 6.6 cm to 8 cm from the distal end is a section of bare core wire, the section of the coating appears to be missing.The wire guide coating from the bare section of core wire was not provided with the return.No rough surfaces or kinks are found along the wire guide.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use indicates, "this wire guide may be left in place when used under normal conditions in conjunction with, and according to the instruction for, a compatible cook electrosurgical (es) device." the product involved in this report, a 0.21 in metii-21-480 wire guide, was used with the 5-4-3 tip style contour ercp cannula from boston scientific.However, the boston scientific catalog recommends the cannula be used with a.018 in wire guide.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.The likelihood of occurrence is considered remote.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.Additional comments regarding this report: based on the information provided that the cook wire guide was used with an incompatible device, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) the physician used a cook tracer metro direct wire guide (metii-21-480).At the beginning of the case, the doctor cannulated with another manufacturers cannula [recommended wire guide diameter to be used with this cannula is.018 in].The assistant advanced the metii-21-480 [.021 in] through the proximal end of the catheter.The assistant could feel the wire sticking a little bit.When she removed the wire guide she could see the coating of the wire was separating from the wire and the tip.They removed it completely and got a new metii-21-480 and the rest of the case went fine and was finished successfully with the second wire guide.

• 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: 6249382
• MDR Text Key: 64930759
• Report Number: 1037905-2017-00019
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002268623
• UDI-Public: (01)00827002268623(17)191102(10)W3788333
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: METII-21-480
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2016
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2016
• 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
• Treatment: OLYMPUS DUODENOSCOPE, UNKNOWN MODEL