MAUDE Adverse Event Report: COOK ENDOSCOPY ACROBAT® 2 CALIBRATED TIP WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G47616
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.The photo shows a piece of wire guide coating that has frayed and come off of the wire guide.From the photo provided, we cannot confirm the location or extent of the damage on the wire guide.Although the report suggests the damage is on the distal end of the wire guide; the silver markings are not visible in the photo to locate the damage.Per the photo provided, we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photo provided and statements describing the event.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use (ifu) 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 ifu 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 acrobat® 2 calibrated 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: 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 acrobat 2 calibrated tip wire guide.The wire stripped during the last balloon sweep.Part of the wire detached.They completed the rest of the procedure, including a balloon cholangiogram, with another wire (cook tracer metro direct wire guide).The wire fragment was then retrieved with cook captura biopsy forceps.Based on the picture provided and the additional questions answered, a piece of the wire guide coating detached in the small bowel.
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved and the photos provided in the report confirmed the report.There is wire guide coating damage near the distal end.Approximately 5.7 cm to 13.7 cm from the distal end is a section of exposed core wire.A section of the coating approximately 3.9 cm long is hanging from the wire guide, the coating still attached at approximately 9.7 cm from the distal end.A section of coating approximately 7.8 cm long was returned that was separated from the wire guide.The wire guide is bent approximately 15.6 cm from the distal end.Small rough surfaces are found along the wire guide approximately 34.5, 38, 67, 70, 79, and 82.5 cm from the proximal end.Due to the condition of the returned device, it cannot be determined if any sections of the coating are missing.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 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 (ifu) 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 ifu 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 acrobat® 2 calibrated 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: 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.H3 other text : investigation evaluation: our evaluation of the product said to be involved and the photos provided in the report confirmed the report.There is wire guide coating damage near the distal end.Approximately 5.7 cm to 13.7 cm from the distal end is a section of exposed core wire.A section of the coating approximately 3.9 cm long is hanging from the wire guide, the coating still attached at approximately 9.7 cm from the distal end.A section of coating approximately 7.8 cm long was returned that was separated from the wire guide.The wire guide is bent approximately 15.6 cm from the distal end.Small rough surfaces are found along the wire guide approximately 34.5, 38, 67, 70, 79, and 82.5 cm from the proximal end.Due to the condition of the returned device, it cannot be determined if any sections of the coating are missing.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 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 (ifu) 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 ifu 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 acrobat® 2 calibrated 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: 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: ACROBAT® 2 CALIBRATED TIP 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: 7514438
• Report Number: 1037905-2018-00204
• Device Sequence Number: 1524327
• Product Code: OCY
• UDI-Device Identifier: 00827002476165
• UDI-Public: (01)00827002476165(17)201129(10)W3998580
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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 Model Number: G47616
• Device Catalogue Number: AWG2-35-450
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2018
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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: OLYMPUS 190 DUODENAL ENDOSCOPE