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

Catalog Number HBD-W-12-13.5-15

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter section: occupation unknown.Continued from concomitant medical products and therapy dates section: boston scientific wire guide.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with no sign of damage to the sheath or balloon.During a function test a ds-60cc syringe from our stock was attached to the inflation port and water was injected.The balloon would not inflate due to a blockage inside the tubing.The device was soaked in hot water and the balloon still wouldn't inflate.The balloon was cut off the tubing and attached to a tb adaptor and the distal end clamped off.The balloon was inflated with water and 2 pin holes were noted in the middle to proximal portion of the balloon material.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.A hole in the balloon material can occur if the balloon material comes into contact with a sharp object or a burr in the endoscope channel.Prior to distribution, all hercules 3 stage wire guided 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.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.

Event Description

The physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The physician detected the balloon was leaking during the procedure.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: 10303611
• MDR Text Key: 234285112
• Report Number: 1037905-2020-00283
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 10827002517964
• UDI-Public: (01)10827002517964(17)211213(10)W4156877
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2021
• Device Catalogue Number: HBD-W-12-13.5-15
• Device Lot Number: W4156877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• 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
• Patient Age: 59 YR
• Patient Weight: 70