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

Catalog Number HBD-W-15-16.5-18

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

During dilation of the stenosis in caecum, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported [that] the balloon did not deflate after dilation.Staff had to pull out the endoscope completely during the exam to cut the balloon.When the sheath was pulled out through the working channel, it broke and the ide had to pull it out through the distal tip.There was no reportable information at this time.The device was evaluated on 08 january 2024 with the catheter broken at 74.5cm distal from the handle [subject of report].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): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 8002454707
• MDR Report Key: 18633332
• MDR Text Key: 334558134
• Report Number: 1037905-2024-00059
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 10827002517971
• UDI-Public: (01)10827002517971(17)260828(10)W4759496
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-15-16.5-18
• Device Lot Number: W4759496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2023
• 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
• Treatment: ALLIANCE FROM BOSTON; COLONOSCOPE PENTAX EC 38 I 20 CF
• Patient Age: 73 YR
• Patient Sex: Male