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

Catalog Number HYB-48015

Device Problems Detachment Of Device Component (1104); Peeled/Delaminated (1454); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 coil spring is still attached to the distal end of the wire guide.However, the coil spring has started unraveling 3.4 cm from the distal end of the wire guide.The coil spring has unraveled to approximately 34 cm in length.Approximately 3.3 cm of the distal end of the core wire is exposed.No rough surfaces or kinks are found along the wire guide.No portions of the wire guide appear to be missing.The wire guide was returned inside of the wire guide holder.It appears the wire guide holder may not have been flushed.No fluid is present inside of the returned wire guide holder.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 product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The instructions for use instructs 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 instructs 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 hybrid wire guides are subjected to a visual inspection 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 acton: 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 additional information provided that the wire guide was not flushed 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

In preparation for a procedure, the user selected a cook tracer hybrid wire guide.As the user was taking the device out of the package, the tip of the wire guide stripped and unraveled.Another device was on hand to complete the procedure.

• Brand Name: TRACER HYBRID 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: 6608488
• MDR Text Key: 76768769
• Report Number: 1037905-2017-00341
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002226593
• UDI-Public: (01)00827002226593(17)200403(10)W3847596
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2017

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: No Information
• Device Catalogue Number: HYB-48015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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