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

Model Number G51796

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: merit medical big60 inflation device.Investigation evaluation: our laboratory evaluation of the product said to be involved determined there was a break in the catheter.During a visual examination, a crack was observed approximately 20.5 cm from the distal end.The blue switch and clear adapter located at the proximal end of the balloon were missing and not included in the return.The white cap located at the proximal end of the wire guide was also not included in the return.The wire guide was kinked and unable to be removed due to the presence of a crack in the catheter.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: the additional information received indicated that the device was used in the common bile duct, which requires use of a duodenoscope.This is outside the intended use and a likely cause for the reported observation as the damage is near the area where the device would travel across the elevator and be flexed.The intended use in the instructions for use instructs the use: "this device is used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.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 additional comments regarding this report: based on the information provided that this was used against the intended use, 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 Description

During an endoscopic procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon was bent at the guidewire, and it would not pass through.This event was not reportable at the time.On 13-nov-2019, the device was returned and there was a break in the blue 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
• 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: 9432659
• MDR Text Key: 218710600
• Report Number: 1037905-2019-00747
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517967
• UDI-Public: (01)00827002517967(17)220906(10)W4258209
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2022
• Device Model Number: G51796
• Device Catalogue Number: HBD-W-12-13.5-15
• Device Lot Number: W4258209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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