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

Catalog Number FS-LT-35-260

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: cook fusion omni-tome sphincterotome (fs-omni), pediatric biopsy forceps, unknown make or model, cook tracer hybrid wire guide (hyb-48015).Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The loop tip of the wire guide has uncoiled.One of the two coil springs, and possibly part of the wire guide coating, is missing from the distal end of the wire guide.The other of the two coil springs appears to be intact on the distal end of the wire guide.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.The detached coil spring was not returned with the device.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all fusion loop tip 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 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 Description

During an esophagogastroduodenoscopy (egd), the physician used a cook fusion loop tip wire guide.The distal end of the wire unraveled in the pseudocyst.A portion of the device was removed using a pediatric biopsy forcep.A different wire guide was used to complete the procedure.

Manufacturer Narrative

On 06/30/2016, emdr 1037905-2016-00193 was submitted with incorrect information.Outcomes attributed to adverse event indicated that a patient death had occurred.In this event, a patient death did not occur.Concomitant products: cook fusion omni-tome sphincterotome (fs-omni), pediatric biopsy forceps, unknown make or model, cook tracer hybrid wire guide (hyb-48015).Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The loop tip of the wire guide has uncoiled.One of the two coil springs, and possibly part of the wire guide coating, is missing from the distal end of the wire guide.The other of the two coil springs appears to be intact on the distal end of the wire guide.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.The detached coil spring was not returned with the device.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all fusion loop tip 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 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.

• Brand Name: FUSION LOOPTIP 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: 5759803
• MDR Text Key: 48511925
• Report Number: 1037905-2016-00193
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002509764
• UDI-Public: (01)00827002509764(17)180624(10)W3588907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-LT-35-260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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