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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; KNQ, DILATOR, ESOPHAGEAL
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COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number HBD-W-12-13.5-15
Device Problems Fracture (1260); Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation unknown.Concomitant medical products: alliance inflation gun.This investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
 
Event Description
During an esophagogastroduodenoscopy (egd), the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon was leaking from the proximal end.New information, received on 27-feb-2020, noted the balloon was inflated with air.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
Information regarding section e3: occupation unknown.Continued from section d11: boston scientific alliance inflation gun.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record does contain a nonconformance that could potentially be related to the complaint.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.Based on the information provided it is presumed the catheter broke during use which lead to the leakage at the proximal end.In the additional information provided, it is indicated that air was used to inflate the balloon.The ifu states: "this balloon is used in conjunction with an inflation device or manometer and may be filled with sterile water, sterile saline or up to a 1:1 contrast medium mixture consisting of contrast and sterile saline.".Incorrect use of the device likely contributed to the device failure.A corrective action has been initiated to reduce occurrences of catheter cracking, splitting or breaking for hbd-w devices.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all hercules 3 stage wire guided balloon esophageal-pyloric-colonic are subjected to a visual examination and leak test to ensure device integrity.Corrective action: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of the corrective actions and this device is included in the scope of this corrective action investigation.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 hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon was leaking from the proximal end.New information, received on 27-feb-2020, noted the balloon was inflated with air.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
Information regarding section e3: occupation unknown.Continued from section d11: boston scientific alliance inflation gun.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A functional test was performed on the returned device.A cook dilation syringe (ds-60cc-s) was filled with water and attached to the balloon inflation port.The syringe was placed into an inflation handle, and negative pressure was applied to the balloon.After applying negative pressure, the balloon was attempted to be inflated.The balloon would not hold pressure and a leak was observed coming from the proximal end of the balloon.The catheter to balloon connection had been damaged and resulted in leakage at the location.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record does contain a nonconformance that could potentially be related to the complaint.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to 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, based on the information provided it is presumed the catheter broke during use which lead to the leakage at the proximal end of the balloon.In the additional information provided, it is indicated that air was used to inflate the balloon.The ifu states: "this balloon is used in conjunction with an inflation device or manometer and may be filled with sterile water, sterile saline or up to a 1:1 contrast medium mixture consisting of contrast and sterile saline." incorrect use of the device likely contributed to the device failure.A corrective action has been initiated to reduce occurrences of catheter cracking, splitting or breaking for hbd-w devices.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all hercules 3 stage wire guided balloon esophageal-pyloric-colonic are subjected to a visual examination and leak test to ensure device integrity.Corrective action: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of the corrective actions and this device is included in the scope of this corrective action investigation.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 inflated with air, 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 esophagogastroduodenoscopy (egd), the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon was leaking from the proximal end.New information, received on 27-feb-2020, noted the balloon was inflated with air.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.
 
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Brand Name
HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
Type of Device
KNQ, DILATOR, ESOPHAGEAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key9820678
MDR Text Key221029044
Report Number1037905-2020-00132
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier10827002517964
UDI-Public(01)10827002517964(17)220313(10)W4190965
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/13/2022
Device Catalogue NumberHBD-W-12-13.5-15
Device Lot NumberW4190965
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Date Manufacturer Received06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OLYMPUS GIF-XP-160 ENDOSCOPE
Patient Age44 YR
Patient Weight50
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