MAUDE Adverse Event Report: COOK ENDOSCOPY D.A.S.H. MULTIPLE SIZE EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number DASH-8.5-12-15

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned without the pre-packaged syringe included.A syringe from the lab stock was pulled and attached to the 3-way stopcock.The balloon was inflated with air and locked in place with the 3-way stopcock.The 3-way stopcock was then opened and the balloon deflated as intended.The length of the catheter was within specifications.On the front of the open pouch, the pouch was marked with the word "sticks" from the user.It is unknown if the user is referring to the pre-packaged syringe contributing to inflation and deflation difficulties of the balloon.As 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.The user did not indicate if they verified the balloon integrity prior to use.The instructions for use state: "verify balloon integrity prior to use by attaching enclosed pre-measured syringe to stopcock and inflating with air only.If any leakage is detected, do not use.¿ 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 visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all d.A.S.H.Multiple size extraction balloons 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: 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 unknown procedure, the physician chose a cook d.A.S.H.Multiple size extraction balloon.The reporter stated that there was "a bad balloon channel" and that they had difficulties deflating the balloon.The physician was able to remove the balloon and used another of the same device to complete the procedure.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned without the pre-packaged syringe included.A syringe from the lab stock was pulled and attached to the 3-way stopcock.The balloon was inflated with air and locked in place with the 3-way stopcock.The 3-way stopcock was then opened and the balloon deflated as intended.The length of the catheter was within specifications.On the front of the open pouch, the pouch was marked with the word "sticks" from the user.It is unknown if the user is referring to the pre-packaged syringe contributing to inflation and deflation difficulties of the balloon.As 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.The additional information provided indicated that the balloon inflated properly prior to use.The instructions for use state: "verify balloon integrity prior to use by attaching enclosed pre-measured syringe to stopcock and inflating with air only.If any leakage is detected, do not use.¿ 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 visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all d.A.S.H.Multiple size extraction balloons 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: 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 laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned without the pre-packaged syringe included.A syringe from the lab stock was pulled and attached to the 3-way stopcock.The balloon was inflated with air and locked in place with the 3-way stopcock.The 3-way stopcock was then opened and the balloon deflated as intended.The length of the catheter was within specifications.On the front of the open pouch, the pouch was marked with the word "sticks" from the user.It is unknown if the user is referring to the pre-packaged syringe contributing to inflation and deflation difficulties of the balloon.As 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.The additional information provided indicated that the balloon inflated properly prior to use.The instructions for use state: "verify balloon integrity prior to use by attaching enclosed pre-measured syringe to stopcock and inflating with air only.If any leakage is detected, do not use.¿ 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 visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all d.A.S.H.Multiple size extraction balloons 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: 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 unknown procedure, the physician chose a cook d.A.S.H.Multiple size extraction balloon.The reporter stated that there was "a bad balloon channel" and that they had difficulties deflating the balloon.The physician was able to remove the balloon and used another of the same device to complete the procedure.Additional information provided on (b)(6) 2018 indicated that the balloon's integrity was verified prior to use and that an olympus endoscope was used with this device.

• Brand Name: D.A.S.H. MULTIPLE SIZE EXTRACTION BALLOON
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7238063
• MDR Text Key: 99775676
• Report Number: 1037905-2018-00041
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002256200
• UDI-Public: (01)00827002256200(17)181009(10)W3926887
• Combination Product (y/n): N
• PMA/PMN Number: K953951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

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
• Device Operator: No Information
• Device Catalogue Number: DASH-8.5-12-15
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - UNKNOWN MAKE AND MODEL; OLYMPUS ENDOSCOPE - UNKNOWN MODEL