MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570650
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex biliary rx uncovered stent was to be used to treat a 2 1/2 cm malignant lesion in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during deployment, a "popped" was felt and the stent was not deployed.The stent was removed from the patient fully covered by the outer sheath.Reportedly, the blue outer sheath near the guidewire access port was noted to be broken.The procedure was completed with another wallflex biliary stent.There were no patient complications as a result of this event.The patient condition following the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex biliary rx uncovered stent was to be used to treat a 2 1/2 cm malignant lesion in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during deployment, a "popped" was felt and the stent was not deployed.The stent was removed from the patient fully covered by the outer sheath.Reportedly, the blue outer sheath near the guidewire access port was noted to be broken.The procedure was completed with another wallflex biliary stent.There were no patient complications as a result of this event.The patient condition following the procedure was reported to be fine.
Additional Manufacturer Narrative
(b)(4).A fully constrained wallflex biliary rx uncovered stent and delivery system were received for analysis.Visual examination of the returned device found the outer sheath was detached/ broken at the outer diameter: proximal exterior tube- endoscope interface (proximal end of the guidewire access sheath).Three kinks were noted in the inner member at the guidewire access sheath section.Functional evaluation revealed the stent could not be deployed using the delivery system as received; however, the stent was deployed manually by gripping the outer sheath and pulling the tip distally.The stent was measured to be within specifications.No other issues with the stent and delivery system were noted.The damages noted on the returned device were consistent with the application of excessive force during use.Based on the additional information, no dilatation was performed during the procedure.This may have resulted in the application of excessive force, and the damage noted to the device including the kink and broken outer sheath.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7973480
• Report Number: 3005099803-2018-60869
• Device Sequence Number: 13503266
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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 Expiration Date: 04/24/2020
• Device Model Number: M00570650
• Device Catalogue Number: 7065
• Device Lot Number: 0022039902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1