MAUDE Adverse Event Report: COOK ENDOSCOPY ESCORT II EXTRACTION BALLOON

Model Number G21603

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device common name and product code gca biliary catheter for stone removal that may also allow for irrigation and contrast injection; gca.Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described by the user because the condition of the returned device prohibited a full evaluation.The device was returned with the syringe provided with the product.There were no signs of damage to the catheter.The balloon was functionally tested by submerging the balloon in water and injecting air into the balloon.When air was applied to the balloon, bubbles were noted coming from the distal end of the balloon material.Under magnification a pinhole could be seen in the distal end of the balloon material.The syringe that was included with the return was function tested with a lab stock device, no anomalies were detected with the syringe when inflation and deflating the balloon.A visual inspection using magnification was performed on the skive hole underneath the balloon material.Without removing the balloon material the skive appears to be open and smooth.Additionally, due to the condition of the balloon material exhibiting a leak, the device cannot be evaluated for not being able to deflate.Therefore the complaint is 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 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 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 unusual 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.The device did not deballooning [deflate] in the bile duct after bile duct stone removal procedure.The procedure was completed with another like cook extraction balloon.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: 9304530
• MDR Text Key: 219780765
• Report Number: 1037905-2019-00684
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002216037
• UDI-Public: (01)00827002216037(17)200703(10)W4233548
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2020
• Device Model Number: G21603
• Device Catalogue Number: EBL-12-200
• Device Lot Number: W4233548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• 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: 67 YR
• Patient Weight: 66