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

Model Number	M00533260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
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 biliary stent was removed during an endoscopic retrograde cholangiopancreatography (ercp) performed in the common bile duct on (b)(6) 2018.On (b)(6) 2018 the patient had the advanix biliary stent implanted in the cbd with no issues reported.According to the complainant, on (b)(6) 2018 during the scheduled stent removal procedure, when the physician attempted to remove the advanix biliary stent using a standard polypectomy snare, pieces appeared to strip away with minor retraction of the snare.The stent tore tangentially along its length from the distal flange to the distal tip.The physician managed to grab the remaining stent body and remove this with the snare, along with the torn off section.All broken pieces of stent were removed from the patient.The patient was reported to be ok following the procedure.There were no patient complication as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was removed during an endoscopic retrograde cholangiopancreatography (ercp) performed in the common bile duct on (b)(6) 2018.On (b)(6) 2018 the patient had the advanix biliary stent implanted in the cbd with no issues reported.According to the complainant, on (b)(6) 2018 during the scheduled stent removal procedure, when the physician attempted to remove the advanix biliary stent using a standard polypectomy snare, pieces appeared to strip away with minor retraction of the snare.The stent tore tangentially along its length from the distal flange to the distal tip.The physician managed to grab the remaining stent body and remove this with the snare, along with the torn off section.All broken pieces of stent were removed from the patient.The patient was reported to be ok following the procedure.There were no patient complication as a result of this event.
Additional Manufacturer Narrative
Block f10: device code 1069 has been selected to address the reportable event of stent break.Block h10: a visual examination of the returned device was performed and found that the proximal end of the stent was stretched and broken, including the barb.Based on the product analysis, the damage found on the stent is typically made due to grab and pull the stent with the snare during the stent removal.Once the stent is caught with snare, excessive force to remove it can stretch the stent and ultimately breaking the stent.Therefore, 'cause traced to component failure' is selected as the most probable root cause for the complaint.The dhr review was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications.H11: correction to b1:adverse event/product problem change from product problem to adverse event and product problem.Correction to e1: updated zip code to 6150.Correction to e4: initial reporter sent report to fda changed to no.Correction to h1: type of reportable event changed from malfunction to serious injury for intervention required to remove broken stent piece.

• 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: 8059456
• Report Number: 3005099803-2018-61240
• Device Sequence Number: 11238415
• Product Code: FGE
• UDI-Device Identifier: 08714729786634
• UDI-Public: 08714729786634
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: M00533260
• Device Catalogue Number: 3326
• Device Lot Number: 0020223336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention