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

Model Number	G51797
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: boston scientific alliance inflation device.The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.
Event or Problem Description
During an anal dilation procedure, the physician used a cook hercules 3 stage wire guided balloon esophageal-pyloric-colonic.While doing the dilation, the balloon mount over the sheath got disconnected [balloon detaches from catheter].It could be taken out with the help of foreign body forceps.A section of the device did not remain inside the patient's body.The balloon was electively retrieved with forceps due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
During an anal dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.While doing the dilation, the balloon mount over the sheath got disconnected [balloon detaches from catheter].It could be taken out with the help of foreign body forceps.A section of the device did not remain inside the patient's body.The balloon was electively retrieved with forceps due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Continued from boston scientific alliance inflation device investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The condition of the returned device prevented a functional test.A visual examination of the returned device showed that the balloon material had detached from the catheter at the distal end proximal ends of the balloon material.The balloon tip had further detached from the balloon material at the distal end and was not included in the return.It was also observed that the metal bands had moved on the purple tubing.A meeting was conducted with production leadership and production personnel to further investigate balloon detachment from the catheter.During the meeting, it was observed that evidence of glue was present between the blue catheter and purple tubing on the proximal side of the balloon material, evidence of glue was also present at the distal and proximal necks of the balloon material and on the purple tubing on the distal side where the balloon neck joins the balloon.There was no evidence of a hole or rupture in the balloon material.The balloon tip had detached and was not included in the return hence an evaluation of the presence of glue at the balloon tip could not be performed.The meeting concluded that all manufacturing steps had been followed based on a close examination of the returned device and a cause for balloon detachment from the catheter is unknown.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: responses to the additional questions indicated that the balloon was inflated prior to patient contact.This is a likely cause for the reported observation.The instructions for use caution the user: "do not pre-inflate the balloon." prior to distribution, all hercules 3 stage wireguided balloon 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.Additional comments regarding this report: based on the information provided that the device was inflated prior to use, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9131951
• Report Number: 1037905-2019-00565
• Device Sequence Number: 14047503
• Product Code: KNQ
• UDI-Device Identifier: 00827002517974
• UDI-Public: (01)00827002517974(17)220222(10)W4183664
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2022
• Device Model Number: G51797
• Device Catalogue Number: HBD-W-15-16.5-18
• Device Lot Number: W4183664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: OLYMPUS ENDOSCOPE, UNKNOWN MODEL
• Patient Age: 52 YR