MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number	FS-8.5-12-15-A
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the stylet has ruptured through the catheter.During a visual inspection the stylet wire was protruding through the catheter above the intraductal exchange (ide) port on the second set of biocompatible printed markings.The stylet wire was protruding through the catheter at 192.1 cm from the distal end of the proximal hub.Above where the wire is protruding outside the catheter, the catheter has been stretched.Additionally there are several kinks and stretches in the catheter as well, suggesting excessive pressure has been applied to the device.The ide port was observed and was intact.Due to the condition of the device the balloon was unable to be inflated.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 conclusions: 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 states: "if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." a rupture in the catheter by the stylet wire can occur if the device experiences excessive pressure during use.Prior to distribution, all fusion extraction balloon with multiple sizing 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 endoscopy procedure, the physician used a cook fusion extraction balloon with multiple sizing.As reported to customer relations: "wire unraveled from balloon sheath." no further information was available.The device was received for evaluation on (b)(6) 2016.It was noticed at this time that the inner wire had penetrated the catheter.

• Brand Name: FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING
• Common Device Name: GCA, CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5945570
• Report Number: 1037905-2016-00355
• Device Sequence Number: 16246976
• Product Code: GCA
• UDI-Device Identifier: 00827002315372
• UDI-Public: (01)00827002315372(17)160929(10)W3626139
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2016

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-8.5-12-15-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2016
• Initial Report FDA Received Date: 09/13/2016
• 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: ENDOSCOPE (UNKNOWN TYPE)