MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	FS-OMNI-ACRO-35-205
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: dilator (unknown make or model), evolution biliary controlled-release stent - uncovered (evo-10-11-6-b).Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.Both the sphincterotome and wire guide associated with this device were included in the return of the device.The label matches the product returned.Our laboratory evaluation of the returned wire guide confirmed the report.A visual inspection of the returned device was performed.A section at approximately 21.4 cm and 27.2 cm from the distal end has bare core wire exposed.Approximately 5 cm of the wire guide coating has frayed and folded over on itself toward the distal.Due to the condition of the returned device it cannot be determined if any section of the coating is missing.During the evaluation of the wire guide coating, a kink was observed at approximately 5 cm from the distal end and at 198 cm near the proximal end of the device.However, the kink at the distal end is likely the result of the movement difficulty once the wire guide coating stripped.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A review of the wire guide subassembly device history record was reviewed.A nonconformity that could be related to the observation reported by the user was found in the wire guide subassembly.A review of the specification was conducted and a 100% visual inspection of the coating on the wire guide is performed and inspects for any damage or deformities.This inspection process would have removed any products having this nonconformance prior to distribution.Therefore, a discrepancy or anomaly was not observed with the product that was released for distribution.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 instruct the user to do the following: "for best results, wire guide should be kept wet." failure to flush the wire guide can result in damage to the wire guide.The instructions for use precaution the user that this product is not compatible with metal tip devices."if preloaded, use of wire guide with metal tip ercp devices may result in damage to external coating and/or tip of wire guide." the reported observation can occur if the wire guide was used with an incompatible accessory device.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 fusion pre-loaded with acrobat wire guide sphincterotomes 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: 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 preloaded acrobat wire guide.The wire guide stripped during the procedure.When a dilator was being removed, the distal end of the wire guide stripped [coating damage].

• Brand Name: FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6376233
• Report Number: 1037905-2017-00088
• Device Sequence Number: 19022529
• Product Code: KNS
• UDI-Device Identifier: 10827002346014
• UDI-Public: (01)10827002346014(17)191129(10)W3794335
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/03/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: FS-OMNI-ACRO-35-205
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/03/2017
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/03/2017
• 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 ENDOSCOPE (UNKNOWN MAKE OR MODEL)