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

Catalog Number HBD-W-10-11-12

Device Problems Bent (1059); Crack (1135); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our evaluation of the returned device confirmed the report.There is a crack in the catheter approximately 146 cm from the distal end of the device.When we attempted to inflate the device, water was observed leaking from the crack.The balloon appears to be in the uninflated state.The device would not hold pressure in this condition.No part of the device is missing.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 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.Investigation evaluation: our evaluation of the returned device confirmed the report.There is a crack in the catheter approximately 146 cm from the distal end of the device.When we attempted to inflate the device, water was observed leaking from the crack.The balloon appears to be in the uninflated state.The device would not hold pressure in this condition.No part of the device is missing.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 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.

Event Description

During an endoscopy procedure, the physician used a cook hercules 3 stage balloon esophageal.At the opening of the wrapping the tubulure was folded [catheter kinked/bent].On (b)(6) 2015, the device was received at cook for evaluation.Our evaluation determined there is a crack in the catheter approximately 146 cm from the distal end of the device.

Manufacturer Narrative

During an endoscopy procedure, the physician used a cook hercules 3 stage balloon esophageal.At the opening of the wrapping the tubulure was folded [catheter kinked/bent].The device was received at cook for evaluation on 2015.Our evaluation determined there is a crack in the catheter approximately 146 cm from the distal end of the device.An initial mdr was sent on (b)(6) 2015 based on this information.On 10/13/2015 information was received that the device did not make patient contact.Based on the most current information received, this incident no longer meets the reporting criteria of a fda mdr report.During an endoscopy procedure, the physician used a cook hercules 3 stage balloon esophageal.At the opening of the wrapping the tubulure was folded [catheter kinked/bent].The device was received at cook for evaluation on (b)(6) 2015.Our evaluation determined there is a crack in the catheter approximately 146 cm from the distal end of the device.An initial mdr was sent on (b)(6) 2015 based on this information.On (b)(6) 2015 information was received that the device did not make patient contact.Based on the most current information received, this incident no longer meets the reporting criteria of a fda mdr report.

Event Description

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference additional manufacturer narrative notes section for this justification.

• 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: 5076962
• MDR Text Key: 26491570
• Report Number: 1037905-2015-00388
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/13/2015

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 Catalogue Number: HBD-W-10-11-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2015
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• 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