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

Model Number	M00532270
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was opened to be used for an endoscopic retrograde cholangiopancreatography (ercp) in the common bile duct performed on (b)(6) 2021.During preparation, outside the patient, it was noticed that there was a defect on the packaging.It was undetermined whether a sharp object was present on the preparation table.The procedure was successfully completed with a different device.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.

• 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: 11559486
• Report Number: 3005099803-2021-01209
• Device Sequence Number: 16882820
• Product Code: FGE
• UDI-Device Identifier: 08714729787044
• UDI-Public: 08714729787044
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 12/21/2022
• Device Model Number: M00532270
• Device Catalogue Number: 3227
• Device Lot Number: 0026552938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1