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

Model Number	G51795
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter 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.The report could not be confirmed.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.A crack in the catheter can occur if the device experiences excessive pressure during general handling.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.V corrective action: a review of the complaint history was conducted.Corrective action is currently being assessed and a follow up report will be sent.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 on an animal patient, the physician chose a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.[there was] a small pinhole in the product.The following additional information was provided by the customer on 27-feb-2019: when she opened up the package, she noticed a crack in the blue wire [catheter] and a pin-size hole in the tubing.She did not need to test it prior to use, since the hole and crack were visible.The doctor was going to use it for an esophageal stricture.This occurred prior to patient contact; there was no impact to the patient.
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.The report could not be confirmed.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 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 on an animal patient, the physician chose a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.[there was] a small pinhole in the product.The following additional information was provided by the customer on 27-feb-2019: when she opened up the package, she noticed a crack in the blue wire [catheter] and a pin-size hole in the tubing.She did not need to test it prior to use, since the hole and crack were visible.The doctor was going to use it for an esophageal stricture.This occurred 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: 8480593
• Report Number: 1037905-2019-00167
• Device Sequence Number: 1629112
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)211119(10)W4145452
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: No Information
• Device Expiration Date: 11/19/2021
• Device Model Number: G51795
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W4145452
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1