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

Catalog Number HBD-W-18-19-20

Device Problem Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: boston scientific alliance inflation handle, cook 60 cc syringe (unknown model).Investigation evaluation: our evaluation of the returned product confirmed the report.The device exhibited a rupture and approximately 2.2 cm of the balloon material was detached from the catheter.The distal tip of the balloon was detached from the device and was not included in the return.There was a portion of the balloon material missing from the detached balloon.There is evidence of glue on the inner catheter.The catheter proximal to the balloon joint was kinked.There is also a crack/split in the catheter approximately 122.6 cm from the distal end of the proximal hub of the catheter.Due to the condition of the returned device the balloon could not be inflated for functional testing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 conclusions: a definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.With device handling and inspections, every effort is made to minimize reports of this nature.The reporter was unable to specify if the balloon was lubricated prior to advancement through the accessory channel of the endoscope.A possible contributing factor to balloon material damage is inadequate lubrication of the balloon with a lubricating agent.The instructions for use direct the user to "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in endoscopic advancement and balloon preservation.The reporter was unable to specify if negative pressure was applied to the balloon device prior to advancement through the accessory channel of the endoscope.Another possible contributing factor to balloon material damage is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.The instructions for use direct the user "to facilitate passage through the endoscope, apply negative pressure to the device." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.Damage to the balloon material can occur if the balloon is inflated prior to advancement through the endoscope or if the balloon is inflated while partially or fully inside the accessory channel of the endoscope.The instructions for use contain the following precaution: ¿do not pre-inflate the balloon.¿ the instructions for use direct the user to ensure the balloon is completely visualized and positioned before inflation.The instructions for use contain the following warning: ¿during dilation, do not inflate balloon beyond the maximum indicated inflation pressure.¿ over inflation can cause damage to the balloon dilator.The instructions for use state: "inflate balloon to pressure corresponding to smallest balloon diameter and maintain until desired dilation is achieved.To achieve increasingly larger balloon diameters, increase pressure as indicated on catheter tag." another possible contributing factor is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in damage to the balloon material.Prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic dilators 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 balloon was not dilated in the manner specified in the instructions for use (dilate to the smallest balloon diameter first), 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.

Event Description

During a colonoscopy, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon ruptured.They first dilated to 19 mm and it [the balloon] was fine.It ruptured when they went to 20 mm.They had to remove a balloon fragment from the patient with forceps.The doctor indicated that the removed portion would have passed naturally; the portion was removed due to physician preference.

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6112543
• MDR Text Key: 60431868
• Report Number: 1037905-2016-00471
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517981
• UDI-Public: (01)00827002517981(17)190802(10)W3753746
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016

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 Catalogue Number: HBD-W-18-19-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2016
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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: OLYMPUS COLONOSCOPE (UNKNOWN MODEL)