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

Catalog Number METII-35-480

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the photos provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.The photos provided show the distal end of the device and the coil spring assembly has detached from the core wire.A section of uncoiled wire appears to connect the two portions.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos and statements describing the event.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: our evaluation of the photos provided confirmed the report.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.Precautions in the ifu warn: "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." 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 damage.The instructions for use instruct the user to do the following: "prior to removing wire guide from holder, flush with 30 cc of sterile water." failure to flush the wire guide can result in damage to the wire guide."flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first." "note: for best results, wire guide should be kept wet, if applicable." failure to flush the endoscope channel can result in damage to the wire guide.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional test 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.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

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook tracer metro direct wire guide.It was reported that an ercp was performed and it was necessary to use a 0.35 guide wire for cannulation, but the first wire had the distal tip "parched" and the metallic wire exposed.It was necessary to open a second device to perform the procedure.A photo provided depicts the coil spring detached from the core wire.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the photos provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.The photos provided show the distal end of the device and the coil spring assembly has detached from the core wire.A section of uncoiled wire appears to connect the two portions.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos and statements describing the event.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: our evaluation of the photos provided confirmed the report.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 question responses stated, "when the packaging of the material was opened, it was already possible to detect the dry tip, with the exposure of the metallic wire." it is not clarified if the holder was flushed prior to removal.The instructions for use instruct the user to "prior to removing wire guide from holder, flush with 30 cc of sterile water." failure to flush the wire guide can result in damage to the wire guide.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional test 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.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

In preparation for a procedure, the user selected a cook tracer metro direct wire guide.It was reported that an ercp was performed and it was necessary to use a 0.35 guide wire for cannulation, but the first wire had the distal tip "parched" and the metallic wire exposed.It was necessary to open a second device to perform the procedure.A photo provided depicts the coil spring detached from the core wire.Per additional information received on 02/28/2023 no exchanges were completed with this wire guide, because when the packaging of the material was opened, it was "already possible to detect the dry tip, with the exposure of the metallic wire." this occurred prior to use.This occurred prior to use; there was no impact to the patient or user.

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the photos provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.The photos provided show the distal end of the device and the coil spring assembly has detached from the core wire.A section of uncoiled wire appears to connect the two portions.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos and statements describing the event.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: our evaluation of the photos provided confirmed the report.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.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional test 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.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.

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 16363002
• MDR Text Key: 309467303
• Report Number: 1037905-2023-00062
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002256863
• UDI-Public: (01)10827002256863(17)250718(10)W4617971
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

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-35-480
• Device Lot Number: W4617971
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 02/28/2023; 04/06/2023
• Supplement Dates FDA Received: 03/24/2023; 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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: ENDOSCOPE, UNKNOWN MAKE AND MODEL
• Patient Age: 83 YR
• Patient Sex: Male