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

Model Number	G22657
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: olympus visiglide 0.025" wire guide.Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.A functional test was performed on the returned device.A cook quantum biliary inflation device (qbid-1) was filled with water and attached to the balloon inflation port and negative pressure was applied to the balloon.After applying negative pressure, the balloon was inflated.The balloon would not hold pressure and water was seen leaking from two pinholes in the middle of the balloon.An examination of the gold bands near the proximal and distal end of the balloon were verified to be smooth and did not appear to be a contributor to the two pinholes in the middle of the balloon.A visual examination of the catheter showed a kink approximately 6 cm from the distal end of the device.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 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.A pinhole in the balloon can occur if the balloon material comes into contact with a sharp object or a burr in the endoscope channel.Prior to distribution, all quantum ttc biliary 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 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 that this device was used for papillary dilation (against intended use), 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
During an endoscopic papillary balloon dilation (epbd) [off-label use], the balloon was inflated and the user noted that there was a pinhole in the balloon.Therefore, it was replaced with another device to complete the procedure.There have been no adverse effects to the patient reported.

• 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: 7052135
• Report Number: 1037905-2017-00714
• Device Sequence Number: 1211483
• Product Code: FGE
• UDI-Device Identifier: 00827002226579
• UDI-Public: (01)00827002226579(17)191129(10)W3801275
• Combination Product (Y/N): N
• PMA/510(K) Number: K935094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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 Model Number: G22657
• Device Catalogue Number: QBD-10X3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2017
• Device Age: 11 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1