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

Catalog Number	FS-LT-35-260
Medical Device Problem Codes	Bent (1059); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook fusion omni-tome pre-loaded sphincterotome, fs-omni-35-260.Investigation evaluation: our evaluation of the product said to be involved confirmed that the wire guide was kinked.The wire guide has a bend approximately 2 cm from the distal end.The wire guide also has major kinks between 157 cm to 162 cm.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use state the following: "note: for best results, wire guide should be kept wet, if applicable." the instructions for use indicate that the user should "fluoroscopically monitor wire guide advancement in ductal system." prior to distribution, all fusion loop tip wire guides are subjected to a visual inspection and functional testing 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.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion loop tip wire guide.After a very difficult cannulation using the fusion loop tip wire guide (instead of the pre-loaded wire guide), the sphincterotome was hard to peel off [exchange].Finally, they lost access from the bile duct.The wire guide was bent, so it could not be used anymore.They had to use new products and re-cannulate.

• Brand Name: FUSION LOOPTIP WIRE GUIDE
• Common Device Name: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5888880
• Report Number: 1037905-2016-00303
• Device Sequence Number: 13585265
• Product Code: OCY
• UDI-Device Identifier: 00827002509764
• UDI-Public: (01)00827002509764(17)190317(10)W3698551
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: FS-LT-35-260
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2016
• Initial Report FDA Received Date: 08/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FUJINON ED-530XT DUODENOSCOPE
• Patient Age: 74 YR
• Patient Weight: 80