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

Catalog Number HBD-W-18-19-20

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2014

Event Type  malfunction  

Event Description

During an esophagogastroduodenoscopy (egd), a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic was used.The advanced balloon down the endoscope and attempted to inflate using water.The balloon failed to inflate.No section of the device detached inside the endoscope or patient.Our evaluation of the returned device determined that there were breaks in the catheter at the distal end of the device.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 products confirmed the report.There were multiple breaks in the catheter of device resulting in many loose sections of catheter.The device was returned with the balloon cut from the catheter approximately 3 cm from the proximal balloon end.The outer diameter of the catheter was measured in two pieces, near the hub and at the distal end of the catheter that remains attached to the hub, and found to be within specification.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.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, bend 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 esophageal-pyloric-colonic wireguided balloons are subjected to a visual inspection and functioning testing to ensure device integrity.A review of the device history records 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 reassessment results as post market feedback continues to become available.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie friole, manager ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3817452
• MDR Text Key: 21999364
• Report Number: 1037905-2014-00104
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2014

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: 08/15/2016
• Device Catalogue Number: HBD-W-18-19-20
• Device Lot Number: W3322589
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2014
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2013
• 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
• Treatment: ALLIANCE INFLATION GUN (UNKNOWN MODEL NUMBER),; FUJINON ENDOSCOPE (UNKNOWN MODEL NUMBER),; COOK DS-60CC-S DILATION SYRINGE