MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 100 3 STAGE WIRE GUIDED BALLOON

Catalog Number	HBDE-W-18-19-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continued from suspect medical devices: common name: dilator, esophageal.Product code: kcf.The investigation is currently in progress.A follow-up emdr will be sent following the completion of the investigation.
Event or Problem Description
During an esophageal dilation procedure, the physician used a hercules 100 3 stage wire guided balloon.The procedure went as intended and was completed with dilation being completed in three (3) incremental steps to achieve 20 mm of dilation.The balloon was used without any difficulty and worked appropriately both inflating and rapidly deflating throughout the case.There were not any areas of concern that were seen or discussed during or post case.One week after the procedure, the physician had a follow up with the patient who had developed severe supraglottic swelling above the dilation site.Additional information received from the physician states that he believed the balloon was inflated with water to the specified atm for 20 mm of dilation.There was no difficulty with access or advancing the endoscope.No negative pressure was applied to the balloon and we used a rigid endoscope through the mouth (not a flexible endoscope via a channel).No lubrication was used, but this was not a channeled insertion.The supraglottic swelling was treated with antibiotics, steroids, and intensive care unit (icu) observation.Airway symptoms started about five (5) days after surgery.Patient responded quickly.On his last exam, the swelling had significantly improved, but not resolved.The physician is uncertain if the cook device had anything to do with the supraglottic swelling as it was not in the surgical field during dilation.The physician stated that most likely the swelling was from the laryngoscope, however, in his years of practice as a primary laryngeal airway physician, he has not seen a similar complication in this particular circumstance.Due to the uncertainty and out of caution, a report is being sent as the cook device may have caused or contributed to the serious injury that occurred.A section of the device did not remain inside the patient¿s body.The patient required steroids, antibiotics, and observation in the intensive care unit due to supraglottic swelling that developed following the procedure.Other than the swelling and airway symptoms, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Continued from suspect medical devices.Common name: dilator, esophageal.Product code: kcf.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.The user stated "the procedure went as intended and the balloons were used without any difficulty".A device failure was not identified in our review of the provided information.This event appears to be a clinical complication of the procedure.Prior to distribution, all hercules 100 3 stage wire guided balloons are subjected to a visual inspection and functional testing 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 and this represents an isolated occurrence.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.
Additional Manufacturer Narrative
Continued from suspect medical devices common name: dilator, esophageal product code: kcf correction- the summary report designation is incorrect, the report is not a summary report.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.The user stated "the procedure went as intended and the balloons were used without any difficulty".A device failure was not identified in our review of the provided information.This event appears to be a clinical complication of the procedure.Prior to distribution, all hercules 100 3 stage wire guided balloons are subjected to a visual inspection and functional testing 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 and this represents an isolated occurrence.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.

• Brand Name: HERCULES 100 3 STAGE WIRE GUIDED BALLOON
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11398455
• Report Number: 1037905-2021-00091
• Device Sequence Number: 17276052
• Product Code: KCF
• UDI-Device Identifier: 00827002352711
• UDI-Public: (01)00827002352711(17)230831(10)W4380877
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: HBDE-W-18-19-20
• Device Lot Number: W4380877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/02/2021; 04/01/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/25/2021; 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK SPHERE INFLATION DEVICE, CID-60-15; LARYNGOSCOPE, UNKNOWN MAKE OR MODEL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention