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	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.The user provided photos and in one of the photos it appears that the balloon is deflated.The user stated that the balloon would not deflate.Without substantial evidence to contradict the complaint, it is considered confirmed based solely on 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.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.In order to hold the balloon in an inflated state, the stopcock is placed in the closed position.To deflate the balloon, the instructions for use state: "once balloon is endoscopically visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all fusion extraction balloons with multiple sizing are subjected to a visual and functional test to ensure device integrity.The functional test includes an air inflation test to ensure proper balloon function.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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
In preparation for a procedure, the physician chose a fusion extraction balloon with multiple sizing.The balloon was inflated to verify the device function.However, because the balloon would not deflate, it was replaced with another manufacturer's device and the procedure was completed with the replacement device.
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A functional test was performed on the balloon.A syringe was used from our lab stock due to the pre-packaged syringe not being included with the returned device.The syringe was attached to the stopcock that was attached to the inflation port.When the balloon was filled with air, no leaks were present in the balloon material.Once the balloon was inflated, the stopcock was turned to the open position and the balloon then deflated within a few seconds.The skive between the balloon joints appeared to be open and cut smoothly.Since the pre-packaged syringe was not included in the return, we could not fully replicate the customer's experience.The complaint is considered confirmed based solely on 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: a definitive cause for the reported observation could not be determined because the product said to be involved functioned as intended.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.In order to hold the balloon in an inflated state, the stopcock is placed in the closed position.To deflate the balloon, the instructions for use state: "once balloon is endoscopically visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all fusion extraction balloons with multiple sizing are subjected to a visual and functional test to ensure device integrity.The functional test includes an air inflation test to ensure proper balloon function.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 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: 7040294
• Report Number: 1037905-2017-00688
• Device Sequence Number: 13802623
• Product Code: GCA
• UDI-Device Identifier: 00827002315372
• UDI-Public: (01)00827002315372(17)180824(10)W3908800
• Combination Product (Y/N): N
• PMA/510(K) Number: K040129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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-8.5-12-15-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2017
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/22/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1