MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. ECLIPSE TTC WIRE GUIDED BALLOON DILATOR; KNQ, DILATOR, ESOPHAGEAL

Catalog Number ECL-16X5.5

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

During an endoscopy procedure to dilate an esophageal stenosis, a cook eclipse ttc wire guided balloon dilator was used.Balloon leakage was observed during the procedure.No section of the device detached inside the endoscope or pt.A new balloon was used to complete the procedure.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 eval of the returned device confirmed the report.The balloon was inflated using a 60 cc syringe and an inflation handle.A stream of water was observed exiting the balloon due to a pinhole.The balloon would not fully inflate or hold pressure in this condition.There are kinks in the catheter at approximately 25 cm and 57 cm from the hub.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 caution the user that negative pressure is mandatory to maintain balloon deflation.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.A possible contributing factor to balloon pinhole is inadequate lubrication of the balloon with a water soluble lubricant.The instructions for use direct the user to apply a water soluble lubricant to the balloon to allow easier passage through the accessory channel.This activity will aid in endoscopic advancement and balloon preservation.A balloon pinhole 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 also advise to maintain balloon deflation with negative pressure and to completely visualize the balloon endoscopically.The instructions for use contain the following info: "recommended 100% balloon inflation pressure can be found on catheter tag of balloon dilator".Over inflation can cause damage to the balloon dilator, such as pinholes.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 a rupture of the balloon material.Prior to distribution, all eclipse ttc wire guided balloon dilators 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 mfg 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: ECLIPSE TTC WIRE GUIDED BALLOON DILATOR
• 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: 4540670
• MDR Text Key: 20144978
• Report Number: 1037905-2015-00052
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K935094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2017
• Device Catalogue Number: ECL-16X5.5
• Device Lot Number: W3382917
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2015
• Device Age: 12 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• 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
• Treatment: OLYMPUS GIF-IT240 ENDOSCOPE
• Patient Age: 48 YR
• Patient Weight: 88