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

Catalog Number	HBD-W-10-11-12
Medical Device Problem Codes	Crack (1135); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: boston scientific inflation device - unknown model.Investigation evaluation: our laboratory evaluation of the product said to be involved determined that there were cracks in the catheter.The device was returned with a white substance stuck to the catheter and balloon material.The white material is most likely contrast.The pre-loaded wire guide was not included in the return.A functional test could not be performed on the returned device due to the presence of cracks in the catheter.A visual inspection of the catheter showed cracks approximately 121 cm, 221.5 cm and 224.5 cm from the distal end.Kinks were observed approximately 117.3 cm, 124.7 cm and 225 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.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.The additional information provided indicated the balloon dilator did not receive lubrication prior to advancement through the endoscope.The instructions for use direct the user, "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in endoscopic advancement and reduce the likelihood of the catheter kinks.Damage to the catheter can occur if the device experiences excessive pressure during general handling.Prior to distribution, all hercules 3 stage wireguided balloons esophageal-pyloric-colonic are subjected to a visual examination 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.Additional information regarding this report: based on the information provided that lubrication was not applied to the balloon prior to advancement into 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 or Problem Description
During a dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The device was used for dilation of the stenosed site in the large intestine.An olympus endoscope was inserted into the patient first.When the physician inserted the device through the endoscope channel, the catheter became kinked.Therefore, another device was used instead to complete the procedure.There have been no adverse effects to the patient reported.There was no reportable information at this time.The device was received for evaluation on 27-aug-2018 and was found to have two (2) cracks in the catheter.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: 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: 7897796
• Report Number: 1037905-2018-00431
• Device Sequence Number: 165159
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)210507(10)W4062160
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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: 05/07/2021
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W4062160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1