MAUDE Adverse Event Report: COOK ENDOSCOPY TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

Model Number G26856

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

Information regarding suspect medical device: common device name: 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 determined that a portion of the balloon material is missing.The device was returned with no sign of damage to the catheter and the prepackaged syringe was provided in the return.A visual inspection of the returned device determined that the balloon material was ruptured.The ruptured ends of the balloon material do not line up with each other, indicating a portion of the balloon material is missing.Due to the condition of the balloon material a functional test could not be performed.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory 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 evaluation: 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.In the report, the user stated they tested the integrity of the balloon.The balloon inflated properly prior to advancement into the endoscope.A split or rupture in the balloon material can also occur if the balloon has come into contact with a sharp object, such as a sharp stone, or possibly a sharp edge in the endoscope accessory channel or if added pressure was applied during extraction.The instructions for use direct the user to, "using fluoroscopic visualization and keeping endoscope elevator open, gently withdraw inflated balloon toward papilla.Warning: do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy.¿ prior to distribution, all tri-ex extraction balloons with multiple sizing 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tri-ex extraction balloon with multiple sizing.The user checked the balloon integrity before use which turned out fine.The user inflated the balloon during the procedure, but it broke.The user has many years of experience using cook product.There was no reportable information at this time.The device was evaluated on 28-june-2018 and our evaluation of the returned device determined part of the balloon material was missing and was not included in the return of the device.This information was communicated to the user facility and the location of the missing section is unknown.The initial reporter stated that a section of the device did not remain inside the patient¿s body; however the location of the missing section detected during our laboratory evaluation is unknown.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
• 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: 7711590
• MDR Text Key: 114946139
• Report Number: 1037905-2018-00328
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002268562
• UDI-Public: (01)00827002268562(17)181031(10)W3935418
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K953951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: G26856
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W3935418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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