MAUDE Adverse Event Report: COOK ENDOSCOPY COOK BALLOON COOK HERCULES 3 STAGE; DILATOR, ESOPHAGEAL

Model Number HBD-18-19-20

Device Problem Material Rupture (1546)

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

Event Date 08/22/2019

Event Type  malfunction  

Event Description

Pt in mpu room 7 for ego procedure.We have switched our product to cook from boston scientific.We used the cook balloon today, the 18-20mm through scope dilator (hurricane is the same i believe).Inflated 18mm in stricture and held for 60 sec then went up to 19mm and then balloon ruptured when we went up to 20mm mark after about 10 sec.Had to repeat the dilation, cut the balloon and redo.This added extra time as well as extra cost when going through 2 balloons instead of 1.During procedure balloon was inflated as directed by physician.Staff applied negative pressure to balloon as instructed, inflated to desired and recommended volume.Balloon was initiated to 18 (4 pressure) 19 (5 pressure) 20 (6 pressure).Inflation was with the big 60 device and we inflated to 6 atmospheric pressure.No tension was noted and physician stated balloon was not inflated.Upon removal, it was noted balloon was inflated and possible burst during procedure.Nothing was retained by pt.No add'l procedures needed and procedure continued after removal.Balloon cook hercules 3 stage balloon, hbd-18-19-20 mft #g31927, lot # w4221939.Fda safety report id# (b)(4).

• Brand Name: COOK BALLOON COOK HERCULES 3 STAGE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY
• MDR Report Key: 9029108
• MDR Text Key: 158851829
• Report Number: MW5089773
• Device Sequence Number: 1
• Product Code: KCF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HBD-18-19-20
• Device Catalogue Number: MFT # G31927
• Device Lot Number: W4221939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR