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

Model Number	M00534230
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Perforation (2001)
Date of Event	02/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was used during a stent placement procedure, performed on (b)(6) 2022.Post procedure, on (b)(6) 2022, the patient came to the emergency room with pain and fever.A ct scan was performed and it was noted that the plastic stent perforated the duodenum wall opposite of the ampulla.On (b)(6) 2022, an endoscopic retrograde cholangiopancreatography procedure was performed.The physician pulled the stent and closed the perforation with an over the scope ovesco clip.There were no information if a new stent was implanted to the patient.The patient remained in the hospital for observation in stable condition.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 medwatch will be filed.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e2114 captures the reportable event of perforation.Patient code e2330 captures the reportable event of pain.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f12 captures the reportable event of serious injury/illness/ impairment.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 medwatch will be filed.Block h11: correction updated b5 correction to block b3 (date of event), d6b (explant date); d7a (sud reprocessed and reused), and h8 (usage of device).
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was used during a stent placement procedure in the common bile duct, performed on (b)(6), 2022.Post procedure, on (b)(6), 2022, the patient came to the emergency room with pain and fever.A ct scan was performed and it was noted that the plastic stent perforated the duodenum wall opposite of the ampulla.An endoscopic retrograde cholangiopancreatography procedure was performed and the physician pulled the stent and closed the perforation with an over the scope ovesco clip.There was no new stent implanted into the patient.The patient remained in the hospital for observation in stable condition.No further information has been obtained 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13789798
• Report Number: 3005099803-2022-01166
• Device Sequence Number: 14409043
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: 08714729787327
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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 Model Number: M00534230
• Device Catalogue Number: 3423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown