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

Model Number	M00534560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure, performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician attempted to deploy the stent, it was noticed that the stent broke.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of stent break.Block h10: the returned naviflex rx delivery system was analyzed, and a visual evaluation noted that the pull wire was fully retracted and it was kinked in several locations.The push catheter was kinked/bent in several locations and it is torn near the handle exposing the pull wire.The suture was detached and it was not returned for analysis, also the suture hole was torn.The advanix rx stent was not returned for analysis.No other issues with the device were noted.The reported event of stent break was not confirmed.Based on the product analysis, the issue occurred during procedure.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Device under tortuous condition due to patient anatomy or customer use/manipulation/maneuvering could have contributed with the damages observed, pull wire and push catheter kinked/bent.Kinks and bends on the delivery system can cause friction between the components at kinked/bent areas, this would result in difficulties to deploy the stent, continued attempts to retract the pull wire/guide catheter or force applied to the device to release the stent can tear the push catheter, suture hole torn indicates that the suture was placed on the device, however it was submitted to tension forces that resulted in the detachment of the suture.The investigation conclusion code for the encountered damages will be selected as adverse event related to procedure.The stent was not returned, it could not be visually inspected in order to confirmed the alleged issue, therefore, no problem detected is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure, performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician attempted to deploy the stent, it was noticed that the stent broke.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10833064
• Report Number: 3005099803-2020-05252
• Device Sequence Number: 2904656
• Product Code: FGE
• UDI-Device Identifier: 08714729787112
• UDI-Public: 08714729787112
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 09/18/2020
• Device Model Number: M00534560
• Device Catalogue Number: 3456
• Device Lot Number: 0022677291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1