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

Catalog Number ECL-12X5.5

Device Problem Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cook, quantum inflation device, qid-1.Information regarding reporter occupation: unknown.Investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the products said to be involved were not provided to cook for evaluation.The lot number provided in the photos matches this report.The label in the photo matches the product reported.The reported issue was confirmed from the 3 pictures provided.The balloon was visible in the pictures and a leak could be seen coming from a pinhole near the proximal end of the balloon.The photos also provided verification of the product and lot information.A complete evaluation could not be performed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The customer indicated that the device was being used to dilate the duodenal papilla.This is outside the intended use for this device.The instructions for use states: "this device is used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon." it also states "do not use this device for any purpose other than stated intended use." additional information provided indicated that negative pressure was not applied to the balloon prior to advancement through the endoscope.A possible contributing factor to a leak in the balloon material is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use direct the user to "maintain balloon deflation with negative pressure." another possible contributing factor for leakage is if the device comes in contact with a sharp object or 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: 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.Additional information regarding in-service: based on the information provided that the device was used on the duodenal papilla and negative pressure was not applied to the balloon prior to advancement through the endoscope, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used an eclipse ttc wire guided balloon dilator.The physician inflated the balloon to dilate the duodenal papilla but the did balloon did not inflate as intended.The physician retracted the balloon from the patient and found out there was a leaking issue.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

Continued from concomitant medical products and therapy dates section: cook quantum.Inflation device, qid-1.Initial reporter section e3: occupation - unknown.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a cook qid-1 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 leak was observed from a pinhole near the proximal end of the balloon material.A visual examination of the catheter also identified a kink located at the 108.2 cm area as measured from the distal tip.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.Photos were also provided with this report.The lot number provided in the photos match this report.The label in the photo matches the product reported.The reported issue was confirmed from the pictures provided.The balloon was visible in the pictures and a leak could be seen coming from a pinhole near the proximal end of the balloon.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.However, the customer indicated that the device was being used to dilate the duodenal papilla.This is outside the intended use for this device.The instructions for use states: "this device is used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.".It also states "do not use this device for any purpose other than stated intended use." additional information provided indicated that negative pressure was not applied to the balloon prior to advancement through the endoscope.A possible contributing factor to a leak in the balloon material is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use direct the user to "maintain balloon deflation with negative pressure." another possible contributing factor for leakage is if the device comes in contact with a sharp object or 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: 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.Additional information regarding in-service: based on the information provided that the device was used on the duodenal papilla and negative pressure was not applied to the balloon prior to advancement through the endoscope, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used an eclipse ttc wire guided balloon dilator.The physician inflated the balloon to dilate the duodenal papilla [abnormal use] but the balloon did not inflate as intended.The physician retracted the balloon from the patient and found out there was a leaking issue.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
• MDR Report Key: 10077172
• MDR Text Key: 220693243
• Report Number: 1037905-2020-00222
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 10827002256306
• UDI-Public: (01)10827002256306(17)210501(10)W4057804
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: ECL-12X5.5
• Device Lot Number: W4057804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJF-260 DUODENOSCOPE
• Patient Age: 58 YR
• Patient Weight: 61