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

Model Number G23038

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: boston scientific microknife xl; bovie electrosurgical generator.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The distal tip of the returned wire guide was discolored black and damaged.The distal tip did not show any evidence of a coil spring, indicating that at least 3 cm of the wire guide is missing.The returned wire guide was 254.9 cm in length.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: the user indicated that the wire guide was left in place when attempting to cut with an unknown cook medical sphincterotome and boston scientific microknife.The roadrunner wire guide is intended to be removed before the initiation of electrosurgical cutting.The instructions for use warn the user: "remove this wire guide before applying electrical current." use of the device against the instructions for use is the most likely cause for the reported observation.Prior to distribution, all roadrunner 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 isolated 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.Additional comments regarding this report: based on the information provided that device wire guide was left in place while applying electric current, 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 a sphincterotomy, the physician used a cook road runner wire guide.During the sphincterotomy a small segment of cook roadrunner guide wire was fractured and retained within the dorsal pancreatic duct.The surgeon reports there was a 'spark and puff of smoke' just prior to the break.The following additional information was received on 02-oct-2019: "a small segment (the flexible tip) of the guidewire was fractured and retained within the dorsal pancreatic duct.A multi-size extraction balloon was inserted into the dorsal duct and inflated to the smallest size alongside the 2 cm segment of retained wire.The balloon was swept through the duct three times without successful retrieval of the wire segment.A cytology brush was utilized in a similar fashion without success.Finally a cook soehendra stent retriever was utilized to dilate the proximal portion of the dorsal duct and also in an attempt to retrieve the guidewire segment unsuccessfully.We were having problems with the electrosurgical generator.The surgeon kept turning to his right and he thinks each time he turned he was actually pulling out the guidewire until the junction of the hardwire and the flexible tip were near the knife and when he fired the electrosurgical generator thinking the guidewire was further in it sparked and fractured the guidewire." the tip of the wire guide remains in the patient's body.Multiple devices were used in an attempt to remove the detached portion of the device.The physician is going to reattempt to retrieve the portion when the stent is removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ROADRUNNER 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: 9218091
• MDR Text Key: 176346781
• Report Number: 1037905-2019-00626
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002230385
• UDI-Public: (01)00827002230385(17)210123(10)W4021551
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: G23038
• Device Catalogue Number: RR-18-260
• Device Lot Number: W4021551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR