MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ESCORT II EXTRACTION BALLOON; No Match

Catalog Number EBL-12-200

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.Continued: common device name: gca biliary catheter for stone removal that may also allow for irrigation and contrast injection.Product code: gca.

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook escort ii extraction balloon.The nurse pre-inflated [ebl balloon] outside of the endoscope.When the physician used ebl balloon [to] pass and pull out one small stone, he found it couldn't deflate.He [then] used a very big force to pull it out of the papilla, [while] still inflated.The physician tried a long time waiting to deflate the balloon, but it still couldn't deflate.Finally he used a very big force to pull it out of the scope to break the 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.

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook escort ii extraction balloon.The nurse pre-inflated [ebl balloon] outside of the endoscope.When the physician used ebl balloon [to] pass and pull out one small stone, he found it couldn't deflate.He [then] used a very big force to pull it out of the papilla, [while] still inflated.The physician tried a long time waiting to deflate the balloon, but it still couldn't deflate.Finally he used a very big force to pull it out of the scope to break the balloon.Per qe evaluation received on 10/05/2022, when this device was evaluated, the balloon was not able to be inflated due to the balloon material being ruptured.The balloon material pieces do not match up, and a section of the balloon material appears to be missing.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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear plastic bag with an open pouch from the lot number provided in the report.The label matches the product returned.The photo provided shows the extraction balloon inflated inside the gi tract, outside of the papilla.Our laboratory evaluation of the product said to be involved could not confirm the report of unable to deflate since the balloon was ruptured in order to remove it from the scope.In the report it states the balloon was broken while trying to pull it out of the endoscope because the balloon would not deflate as expected.The balloon was returned with the provided syringe in the package and the device in the coiled position.The balloon was ruptured.Under magnification the balloon was examined and there was a portion where the balloon material did not match up and a portion appears to be missing.The missing portion of the balloon was not returned with the device.The investigation did not identify a cause of the balloon to not deflate.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: our evaluation of the returned device confirmed the report, the balloon material was ruptured due to it being unable to deflate.A definitive cause for this observation could not be determined because of the state of the returned device.The information provided indicated the balloon functioned properly prior to use.Therefore, the balloon was functioning prior to advancement through the endoscope accessory channel.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.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: ESCORT II EXTRACTION BALLOON
• Type of Device: No Match
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 15439589
• MDR Text Key: 300905310
• Report Number: 1037905-2022-00516
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002216034
• UDI-Public: (01)10827002216034(17)230411(10)W4584115
• Combination Product (y/n): N
• PMA/PMN Number: K953951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Catalogue Number: EBL-12-200
• Device Lot Number: W4584115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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: ENDOSCOPE - OLYMPUS, UNKNOWN MODEL
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 52 KG