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

Catalog Number METII-21-260

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/05/2022

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook tracer metro direct wire guide.It was reported that the tip came off during the procedure.It was reported that a section of the device did not remain inside the patient¿s body; the location of the missing portion is unknown.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: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our evaluation of the returned device confirmed the report.The outer black coating of the wire guide tip separated from the outer orange spiral coating and detached from the core wire guide.This damaged area is located near the distal end of the wire guide.The inner core wire is visible at the damaged area beginning 254.4cm from the proximal tip.The distal tip is frayed and the spring assembly has been stretched reaching 257.6 cm.There is approximately 2.4 cm missing from the length which was not returned.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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.The instructions for use instruct the user to do the following: "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.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 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 and this represents an unusual occurrence.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.

Manufacturer Narrative

B5- the quantity has been corrected from one used device to one used device and one prior to use device.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used two (2) cook tracer metro direct wire guides.It was reported that the tip came off on one device prior to use and the other during the procedure.It was reported that a section of the device did not remain inside the patient¿s body; the location of the missing portion is unknown.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.

• 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: 15352436
• MDR Text Key: 304595190
• Report Number: 1037905-2022-00499
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002557052
• UDI-Public: (01)10827002557052(17)250113(10)W4555469
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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-21-260
• Device Lot Number: W4555469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• 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: COOK GT-1-LT GLO-TIP ERCP CATHETER; OLYMPUS GIF-190-VR ENDOSCOPE