MAUDE Adverse Event Report: COOK ENDOSCOPY ECLIPSE TTC WIRE GUIDED BALLOON DILATOR; KNQ, DILATOR, ESOPHAGEAL

Catalog Number ECL-12X5.5

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Continued from concomitant medical products and therapy dates section: cook quantum inflation device, qid-1, cook tracer metro direct wire guide, metii-35-480.Initial reporter section: occupation - unknown.Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.The stylet was not included as part of the return.Our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a 60cc syringe was filled with water and attached to the balloon inflation port.After applying negative pressure, inflation of the balloon was attempted.The balloon would not hold pressure and a leakage was observed from 3 pinholes in the balloon material.2 of the pinholes were in the center of the balloon and 1 pinhole was at the proximal end of the balloon.A visual examination of the catheter also showed 2 kinks located at the 31cm area and 116cm area as measured from the distal tip of the device.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 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.A possible contributing factor to a pinhole/hole in the balloon material is if the balloon material comes into contact with a sharp object or a burr in the endoscope accessory channel.Prior to distribution, all eclipse ttc wire guided balloon dilators are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: 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 esophagogastroduodenoscopy (egd), the physician used a cook eclipse ttc wire guided balloon dilator.The physician advanced the device through the wire guide to the desired position and inflated the balloon.The physician was unable to see the balloon image under the radiography.The device was retracted from the patient and the balloon was found to be leaking.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: ECLIPSE TTC WIRE GUIDED BALLOON DILATOR
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• 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: 10313326
• MDR Text Key: 241379139
• Report Number: 1037905-2020-00286
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 10827002256306
• UDI-Public: (01)10827002256306(17)220116(10)W4167518
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2022
• Device Catalogue Number: ECL-12X5.5
• Device Lot Number: W4167518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Date Manufacturer Received: 06/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2019
• 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: 73 YR
• Patient Weight: 63