MAUDE Adverse Event Report: COOK ENDOSCOPY ESCORT II EXTRACTION BALLOON

Catalog Number EBL-12-200

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Common name: biliary catheter for stone removal that may also allow for irrigation and contrast injection.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.The prepackaged syringe that was supplied with the balloon 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, pressure was released from the syringe and the balloon deflated within a few seconds.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 information provided indicated the balloon functioned properly prior to use.Therefore, the balloon was functioning prior to advancement through the endoscope.The instructions for use (ifu) states, "once balloon is endoscopically visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all escort ii extraction balloon 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook escort ii extraction balloon (ebl-12-200).The ebl balloon did not deballooning [deflate] in the bile duct after the bile duct stone removal procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ESCORT II EXTRACTION BALLOON
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7812587
• MDR Text Key: 118406235
• Report Number: 1037905-2018-00378
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002216037
• UDI-Public: (01)00827002216037(17)190424(10)W4059220
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Catalogue Number: EBL-12-200
• Device Lot Number: W4059220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• 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
• Patient Age: 64 YR
• Patient Weight: 76