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

Catalog Number	HBD-W-8-9-10
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	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook sphere inflation device, cid-60-15.Investigation evaluation: our laboratory evaluation of the product said to be involved determined that there was a crack in the catheter.A functional test could not be performed; however, the balloon was lubricated and advanced through an olympus gif-q20 endoscope with a 2.8 mm channel.The balloon advanced through the endoscope without difficulty and exited the distal end.During a visual examination, a crack was observed in the catheter approximately 126.5 cm from the distal end, kinks were observed in the catheter approximately 124 cm, 125.5 cm and 126 cm from the distal end.A product specific discrepancy or anomaly was not observed during our laboratory analysis of the returned product.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: the user indicated lubrication was not applied to the balloon prior to advancement.This is the most likely cause for the reported observation.A contributing factor to difficulty with balloon advancement is failure to apply lubrication to the balloon prior to advancement.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 balloon preservation.Damage to the catheter can occur if the device experiences excessive pressure during general handling.Cracks and kinks were observed along the length of the catheter suggesting the device received excess pressure.The instructions for use direct the user: "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." this activity will aid in device preservation.Prior to distribution, all hercules 3 stage wireguided balloons esophageal-pyloric-colonic are subjected to a visual examination to ensure device integrity.There were no non-conformances for the lot number said to be involved.A discrepancy or anomaly was not observed with the product that was released for distribution.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 comments regarding this report: based on the information provided that lubrication was not applied to the balloon prior to advancement, a cook representative has contacted 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 an esophagogastroduodenoscopy with dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.[the user] had difficulty getting the balloon to exit the endoscope to pass through the stricture, which caused the device to kink.To finish the procedure, a [competitor's] wire guided balloon [was used] and then followed that with another cook dilation balloon to complete the procedure.There was no reportable information at this time.The device was received for evaluation on 12-feb-2019 and was found to have a crack 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: 8398666
• Report Number: 1037905-2019-00111
• Device Sequence Number: 19326825
• Product Code: KNQ
• UDI-Device Identifier: 00827002517998
• UDI-Public: (01)00827002517998(17)211016(10)W4132718
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: 10/16/2021
• Device Catalogue Number: HBD-W-8-9-10
• Device Lot Number: W4132718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1