MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-A

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) a cook fusion quattro extraction balloon was used.At the end of the procedure, the balloon failed to deflate.They disconnected the syringe and purged the air, then reconnected the syringe and suctioned the air to deflate the balloon.The procedure was completed with this device with no harm to the pt.A section of the device did not remain inside the pt's body.The pt did not require any add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effect due to this occurrence.

Manufacturer Narrative

Investigation eval: our eval of the returned device confirmed the report.The balloon was returned with one syringe still connected to the proximal hug (syringe #1) and one syringe unattached (syringe 32).Syringe #1 was pressed and released and the balloon would not deflate.With a small amount of retraction assistance on syringe #1 plunger the balloon would deflate.Syringe#1 was removed from the proximal hub.The plunger of syringe #1 was removed.The plunger and inside of syringe #1 were blown with compressed air to remove any potential moisture or debris from the syringe.The plunger was reinserted into syringe #1 and reattached to the hub.When syringe #1 was pressed and released, the balloon deflated as intended.The balloon was advanced into an olympus gif q20 2.8 endoscope in a simulated upper gi position with the tip in a retroflexed position to simulate a worst case situation.With the device in the endoscope in a retroflexed position, syringe #1 was pressed and released.The balloon inflated and deflated as intended.Syringe #1 was attached to the hub of the balloon and tested.The balloon would inflate and deflate as intended with syringe #2.The balloon was advanced into an olympus gif q20 2.8 endoscope in a simulated upper gi position with the tip in a retroflexed position to simulate a worst case situation.With the device in the endoscope in a retroflexed position, syringe #2 was pressed and released.The balloon inflated and deflated as intended.The stopcock was checked for functionality.When the stopcock is in the closed position, the balloon would not deflate, functioning as intended.When the stopcock was in the open position it allowed the balloon to deflate and functioned as intended.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our lab 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 conclusions: according to the info provided in the report, the balloon integrity was verified prior to use by inflating the balloon.Therefore, the balloon was functioning prior to advancement through the endoscope.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the lab setting.Due to a variety of clinical conditions such as pt anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our lab analysis.This limits our ability to conclusively determine a cause.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 the duodenum, turn stopcock to the open position and deflate balloon".A kink in the catheter can contribute to balloon deflation difficulty by blocking the inflation lumen.This can occur if the extraction balloon receives excessive pressure during product handling or advancement through the endoscope.The instructions for use direct the user to advance the deflated balloon in short increments through the accessory channel until it is visualized exiting the endoscope.This activity will aid in device preservation.Prior to distribution, all fusion quattro 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 mfg requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Qa will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3944093
• MDR Text Key: 21524990
• Report Number: 1037905-2014-00159
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W3388025
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/26/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PENTAX SIDE-VIEWING ENDOSCOPE (UNK MODEL)