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

Catalog Number HBD-W-12-13.5-15

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

During an esophagogastroduodenoscopy (egd), a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic was used.As the catheter exited the end of the endoscope, they noticed that the sheath was split.The balloon was never inflated as this was noticed before dilation occurred.The procedure was completed with a new device.Our evaluation of the returned device confirmed a 1cm section of the catheter is missing and was not included in the return of the device.This info was communicated back to the user facility, and the location of missing section is unk.The reporter stated 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.The catheter is broken 130 cm from distal end.Small section of catheter less than 1 cm is missing.The balloon is still in the fluted uninflated state.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, 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 experienced 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.

• 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 fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4751420
• MDR Text Key: 20071349
• Report Number: 1037905-2015-00173
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090183
• 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: 04/03/2015

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: 02/09/2018
• Device Catalogue Number: HBD-W-12-13.5-15
• Device Lot Number: W3537366
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/03/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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 190 UPPER GI ENDOSCOPE