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

Model Number	M00534350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography in the common bile duct performed on (b)(6) 2019.According to the complainant, during the procedure, when they attempted to deploy the advanix biliary stent in the middle part of the choledochus, the stent was broken into pieces.The broken stent was removed from the patient with the use of snare.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and ok.
Additional Manufacturer Narrative
Block f10: problem code 1069 captures for the reported event of stent broken.Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Block h11: correction to e1: initial reporter first name updated to (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography in the common bile duct performed on (b)(6) 2019.According to the complainant, during the procedure, when they attempted to deploy the advanix biliary stent in the middle part of the choledochus, the stent was broken into pieces.The broken stent was removed from the patient with the use of snare.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and ok.

• 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: 8739763
• Report Number: 3005099803-2019-03276
• Device Sequence Number: 2371773
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: 11/18/2020
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0022958499
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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