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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY QUANTUM TTC PYLORIC BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL

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COOK ENDOSCOPY QUANTUM TTC PYLORIC BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number QDP-20X5.5
Device Problems Hole In Material; Use of Device Problem
Event Date 06/10/2016
Event Type  Malfunction  
Manufacturer Narrative

Concomitant product: boston scientific inflation handle, cook syringe (unknown type). Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation. The report could not be confirmed. 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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. A definitive cause for the reported observation could not be determined. The additional information provided indicated the balloon did not receive lubrication prior to advancement through the endoscope. This is the most likely cause for the reported observation. The instructions for use direct the user to "apply a water soluble lubricant to balloon to allow easier passage through accessory channel. " this activity will aid in endoscopic advancement and balloon preservation. Another possible contributing factor to balloon damage is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope. The instructions for use direct the user, "prior to insertion of balloon dilator, 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. Damage to the balloon material 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 balloon. ¿ prior to distribution, all quantum ttc pyloric balloon dilators are subjected to a visual examination 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: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. 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.

 
Event Description

During an esophagogastroduodenoscopy (egd), the physician used a cook quantum ttc pyloric balloon dilator. The quantum ttc pyloric balloon was opened [and taken] out of the pack and reverse suction was used using an alliance gun & cook syringe. The balloon was entered down the endoscope and a hole was noted when attempting to inflate. Another device was used to complete the procedure.

 
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Brand NameQUANTUM TTC PYLORIC BALLOON DILATOR
Type of DeviceKNQ, 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 Key5768877
Report Number1037905-2016-00194
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/10/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberQDP-20X5.5
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/10/2016
Device Age4 mo
Event Location Hospital
Date Manufacturer Received06/10/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/29/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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