MAUDE Adverse Event Report: COOK ENDOSCOPY QUANTUM TTC BILIARY BALLOON DILATOR; FGE, BILIARY CATHETER AND ACCESSORIES

Catalog Number	QBD-8X3
Medical Device Problem Codes	Hole In Material (1293); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: olympus/visiglide wire guide.025, boston alliance ii inflation handle.Investigation evaluation: our evaluation of the returned biliary dilation balloon confirmed the report.During our evaluation, the balloon was inflated with water using a quantum biliary inflation device.During inflation of the balloon, we observed water streaming out of the balloon material near the distal in the of the balloon.No portion of the balloon material 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 additional information provided indicated the balloon did not receive lubrication and negative pressure prior to advancement through the endoscope.This is the most likely cause for this observation.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.The instructions for use caution the user that negative pressure is mandatory to maintain balloon deflation.The instructions for use direct the user to introduce the deflated balloon into the accessory channel.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.The instructions for use state: the duodenoscope must remain as straight as possible with the elevator in the open position when advancing or withdrawing the balloon dilator.Prior to distribution, all quantum ttc biliary balloon dilator 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: 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 or Problem Description
The following information was provided via the cook shared service center on (b)(6) 2016: the physician used the cook quantum ttc biliary balloon dilator for an endoscopic papillary balloon dilation (epbd) to remove a common bile duct stone.First, the endoscope was inserted near the papilla area followed by wire guided cannulation (olympus/visiglide 2 wire guide) in the common bile duct.Then, the quantum ttc biliary balloon dilator was inserted into papilla over the wire guide.The user attempted to inflate the balloon, however the balloon would not inflate due to a hole.Another device was used instead to complete the procedure.No adverse effects to the patient were reported.On 04/04/2016, clarifying information was received confirming that the complaint device was used in the papilla.

• Brand Name: QUANTUM TTC BILIARY BALLOON DILATOR
• Common Device Name: FGE, BILIARY CATHETER AND ACCESSORIES
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5569573
• Report Number: 1037905-2016-00080
• Device Sequence Number: 405388
• Product Code: FGE
• UDI-Device Identifier: 00827002226562
• UDI-Public: (01)00827002226562(17)160809(10)W3318551
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K935094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: QBD-8X3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2016
• Device Age: 30 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2016
• Initial Report FDA Received Date: 04/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS/JF-260V ENDOSCOPE