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

Model Number G51797

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter; occupation: unknown.Investigation evaluation: our laboratory evaluation of the product said to be involved did not confirm the customer report of difficulty advancing the catheter through the working channel of the scope, however a crack in the catheter was confirmed.The balloon was lubricated and attempted to be advanced through the endoscope.Although there were visible cracks and kinks in the catheter, it was able to be fed through the endoscope without difficulty.During a visual examination, a crack in the blue catheter was found at the 130.5 cm location as measured from the distal tip.In addition, 2 kinks were also identified in the blue catheter located at 127.5 cm and 129 cm locations as measured from the distal tip of the catheter.A product-specific discrepancy that could have caused or contributed to this finding was not observed during the 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 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.It is also unknown if lubrication and negative pressure were applied prior to advancing the balloon through the endoscope accessory channel.The instructions for use states: "to facilitate passage through the endoscope, apply negative pressure to the device." the instructions for use also states: "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use (ifu) states: "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.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: 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 Description

During an endoscopic procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon could not leave the operator channel.As soon as the catheter was introduced into the working channel, a strong feeling of friction existed.The catheters were changed without consequences to the patient.This event was not reportable at the time.The device was received on (b)(6) 2019 and it was noted the blue catheter was broken.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

• 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
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 9536206
• MDR Text Key: 219570226
• Report Number: 1037905-2019-00805
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517974
• UDI-Public: (01)00827002517974(17)220522(10)W4218243
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: G51797
• Device Catalogue Number: HBD-W-15-16.5-18
• Device Lot Number: W4218243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1