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

Model Number	M00532260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(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 a previously implanted advanix biliary stent was removed from a patient during a planned stent removal procedure in the common bile duct, performed on approximately two to three weeks following the stent placement procedure.The stent was implanted on (b)(6) 2019 without any issues reported.According to the complainant, approximately two to three weeks following the stent placement procedure, a planned stent removal was performed.The physician noticed that the stent perforated the common bile duct of the patient.The stent was retrieved using forceps and the procedure was completed.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.Block f10, h6: patient code 2001 captures the reportable event of perforation.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 has been made to b5 (event description) and d6 (implant date).
Event or Problem Description
It was reported to boston scientific corporation that a previously implanted advanix biliary stent was removed from a patient during a planned stent removal procedure in the common bile duct, performed on approximately two to three weeks following the stent placement procedure.The stent was implanted on (b)(6) 2019 without any issues reported.According to the complainant, approximately two to three weeks following the stent placement procedure, a planned stent removal was performed.The physician noticed that the stent perforated the common bile duct of the patient.The stent was retrieved using forceps and the procedure was completed.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.**corrected information received on 01oct2019** the stent was implanted on (b)(6) 2019 without any issues reported.The stent was retrieved using a snare and the procedure was completed.

• 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: 9167216
• Report Number: 3005099803-2019-04912
• Device Sequence Number: 3885023
• Product Code: FGE
• UDI-Device Identifier: 08714729787037
• UDI-Public: 08714729787037
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00532260
• Device Catalogue Number: 3226
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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