MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; KNQ, DILATOR, ESOPHAGEAL

Model Number	G51796
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.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.A photo and video were provided to aid the investigation.The lot number was confirmed through the photo.An evaluation of the video provided confirmed the report on leakage from the catheter.Water was seen leaking from a crack in the catheter lumen.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 corrective action has been initiated to reduce occurrences of catheter cracking, splitting or breaking for hbd-w devices.Reference capa 261610.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all hercules 3 stage wire guided balloons esophageal-pyloric-colonic are subjected to a leak test 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.A corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
In preparation for an esophageal dilation procedure, the physician chose a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The user detected wire guide lumen was leaking at preparation stage.There was no use on the patient.The user changed another same device to complete the procedure.The video provided depicts leakage from the catheter.This observation was made prior to patient contact; there was no impact to the patient.
Event or Problem Description
In preparation for an esophageal dilation procedure, the physician chose a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The user detected wire guide lumen was leaking at preparation stage.There was no use on the patient.The user changed another same device to complete the procedure.The video provided depicts leakage from the catheter.This observation was made prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
Continued: section e.Initial reporter; occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the leakage from the catheter.During a visual examination, a crack was observed approximately 211 cm from the distal end.During functional testing, the catheter was found to leak water from this location.The catheter was also kinked approximately 210 cm from the distal end.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A photo and video were provided to aid the investigation.The lot number was confirmed through the photo.An evaluation of the video also provided confirmation of the report on leakage from the catheter.Water was seen leaking from a crack in the catheter lumen.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 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 balloons esophageal-pyloric-colonic are subjected to a leak test 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.A corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
In preparation for an esophageal dilation procedure, the physician chose a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The user detected wire guide lumen was leaking at preparation stage.There was no use on the patient.The user changed another same device to complete the procedure.The video provided depicts leakage from the catheter.This observation was made prior to patient contact; there was no impact to the patient.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9415512
• Report Number: 1037905-2019-00741
• Device Sequence Number: 19477889
• Product Code: KNQ
• UDI-Device Identifier: 00827002517967
• UDI-Public: (01)00827002517967(17)220218(10)W4181091
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: G51796
• Device Catalogue Number: HBD-W-12-13.5-15
• Device Lot Number: W4181091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 11/10/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 12/16/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/18/2019; 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC "PRESSURIZER", UNKNOWN MODEL; ENDOSCOPE UNKNOWN MAKE OR MODEL