MAUDE Adverse Event Report: COOK ENDOSCOPY HOWELL BILIARY INTRODUCER; FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Catalog Number HBI-1

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: cook memory ii double lumen extraction basket, balloon catheter (unknown type), forceps (unknown type), boston scientific hydra jagwire 0.035 inch.Investigation evaluation: our evaluation of the product said to be involved confirmed that the metal side ramp in the distal end of the catheter is not in the lumen.The metal side ramp was returned in a separate clear bag.The outer diameter of the metal side ramp measured to be within specification.During a visual inspection, it was noted that a dried green/yellow substance was on the inside and outside of the howell biliary introducer catheter.This substance was removed through the decontamination process.A small kink is noted on the skived portion of the distal catheter lumen.There is also a yellow mark approximately 1.5 cm in length just distal to the skive suggesting that the catheter lumen rubbed against something.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.Damage to the accessory device lumen/metal ramp can occur if the catheter is clamped by the elevator with great force or if the catheter makes forceful contact with the endoscope.Rough handling of the introducer during use could have caused the damage observed.The instructions for use state: "with endoscope elevator open, introduce device into accessory channel of endoscope." "advance device in small increments until radiopaque capture side ramp is endoscopically visualized exiting scope.Note: capture side ramp must be completely out of endoscope in order to ensure proper operating condition of device." the instructions for use for the howell biliary introducer advises the user that if the introducer is used in conjunction with biopsy forceps, the cups must be closed prior to introduction, advancement, and withdrawal from the introducer.The instructions for use state: "with cups closed, advance forceps through proximal hub of introducer until tip of forceps reaches side ramp." "gently advance forceps out of introducer until it is even with tip of introducer and area targeted for biopsy." "under fluoroscopic monitoring, open forceps cups and advance into targeted area.Using slight pressure on handle, close cups to obtain sample." "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site and retract into introducer." failure to close the cups may result in damage to the introducer.This could have caused the damage observed.The instructions for use indicate, "precautions: if introducer is used in conjunction with needle, needle must be fully retracted into catheter prior to induction, advancement, and withdrawal from introducer.Failure to retract needle may result in damage to introducer." "ensure that needle is completely retracted into sheath, then advance needle catheter through proximal hub on introducer until tip of catheter reaches side ramp." "gently advance needle catheter out of introducer until it is even with tip of introducer and targeted area." "lock hub on needle handle to introducer hub by pressing into place." "slowly advance handle to advance needle out of catheter." "when aspiration biopsy is complete, completely withdraw needle into catheter by puling back on needle handle.Tighten thumbscrew ring on needle handle to lock needle in place."withdraw needle from introducer." prior to distribution, all howell biliary introducers are subjected to a visual inspection to ensure device integrity.This includes an inspection of the position of the side ramp within the tubing 100%.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 a biopsy procedure, the user selected a cook howell biliary introducer for the bile duct biopsy.Accessing the papilla was same as a normal endoscopic retrograde cholangiopancreatography (ercp), and the endoscope position had no notable problem.The bile duct was stenosed at approximately three (3) cm from the papilla, but the user could pass the introducer through and performed the biopsy without a notable problem.However, the user noticed the side ramp marker was detached from the introducer when he attempted to retrieve the introducer.He used a balloon catheter to move the dropped side ramp marker to the common bile duct, and then he captured it using a cook memory ii double lumen extraction basket and successfully took it out of the patient's body.

• Brand Name: HOWELL BILIARY INTRODUCER
• Type of Device: FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• 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: 5815303
• MDR Text Key: 50209554
• Report Number: 1037905-2016-00254
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 00827002229211
• UDI-Public: (01)00827002229211(17)170129(10)W3386561
• Combination Product (y/n): N
• PMA/PMN Number: K961897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HBI-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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 JF-290V ENDOSCOPE
• Patient Outcome(s): Required Intervention