MAUDE Adverse Event Report: COOK ENDOSCOPY 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 Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual inspection of the wire guide was performed and the distal tip of the device appears to have been distorted/damaged due to an unknown force.A section of the core wire approximately 2.5 cm in length is exposed at the distal tip and the coil spring is detaching from the core wire.Approximately 3.4 cm of coating from the distal tip is detached from the device, but connected by the coil spring.The exposed coil spring has been stretched to approximately 26.9 cm.Coating approximately 2.5 cm appears to be missing, but was not returned for evaluation.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A lab meeting with production supervision was held to evaluate the state of the returned device and condition of the distal tip.The review was unable to confirm a manufacturing defect associated with the manufacturing process at the distal end of the wire guide.Devices released for distribution go through multiple inspections to detect such defects.Inspections include visually verifying distal end of wire guide is smooth and free of sharp edges or points and inspecting product for kinks.Therefore, it is unknown how or at what point the tip of the wire guide became damaged/distorted.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 product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.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 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook tracer metro direct wire guide.The physician advanced the device to bile duct first, then to pancreatic duct.They found out the patient has duodenal papilla calcification along with pancreatic lithiasis.After several super-selective [sic], the coating of tip of wire guide peeled off.Another of the same device was used to complete the procedure.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.

• 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 (Section G): 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: 11087033
• MDR Text Key: 251098244
• Report Number: 1037905-2020-00571
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002256863
• UDI-Public: (01)10827002256863(17)230624(10)W4357996
• Combination Product (y/n): N
• PMA/PMN Number: K953951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

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 Expiration Date: 06/24/2023
• Device Catalogue Number: METII-35-480
• Device Lot Number: W4357996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• 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 Age: 46 YR
• Patient Weight: 72