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

Catalog Number HBD-W-18-19-20

Device Problems Material Fragmentation (1261); Use of Device Problem (1670)

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

Event Date 02/19/2015

Event Type  malfunction  

Event Description

During an endoscopy procedure, a cook hercules 3 stage wireguided balloon esophageal-pyloric--colonic was used.While advancing the device through the endoscope, the outer catheter ripped.Our evaluation of the product said to be involved confirmed an approximately 1.5 cm long section of the catheter has detached from the device and was not included in the return.Information regarding the missing section was communicated back to the medical facility.The location of the missing section is unknown.According to the initial reporter, 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.

Manufacturer Narrative

Investigation evaluation: our evaluation of the returned device confirmed the report.Approximately 127 cm from the proximal end is a crack in the catheter.A section of the catheter approximately 1.5 cm long is missing from the device.The outside catheter has separated into two (2) sections but still remains over the inner catheter and attached to the device.The balloon is still in the fluted state and appears to have not been inflated.It would have been impossible to inflate the balloon due to the condition of the catheter.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 use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use direct the user to apply negative pressure to the balloon to facilitate passage through the endoscope.The application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.According to the report lubrication was not applied to the balloon prior to advancement through the endoscope.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 catheter preservation.The instructions for use state: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." kinks and/or bends and/or cracks in the catheter can occur if the device experiences excessive pressure during use and/or general handling.The instructions for use for this product line advise the user to advance the device through the accessory channel in short increments.This activity will aid in device preservation.Prior to distribution, all hercules 3 stage wireguided esophageal-pyloric-colonic 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: 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, 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
• Manufacturer (Section D): WILSON-COOK MEDICAL, INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manager ; 4900 bethania station rd. &; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4644681
• MDR Text Key: 5681598
• Report Number: 1037905-2015-00118
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K090183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2015

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 Expiration Date: 12/31/2016
• Device Catalogue Number: HBD-W-18-19-20
• Device Lot Number: W3374420
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2015
• Device Age: 14 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2013
• 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