MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83775
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Pseudoaneurysm (2605)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced rebleeding, low hemoglobin levels, and permeable pseudoaneurysm after occlusion.The patient presented with a history of pancreatitis, which led to active bleeding.The preferred treatment for this condition is to occlude the pseudoaneurysm using an interventional procedure.On (b)(6) 2024, a non-boston scientific (bsc) coil was placed percutaneously inside the pseudoaneurysm.On (b)(6) 2024, a computed tomography (ct) scan documented that the pseudoaneurysm remains permeable.This is likely due to the use of a single coil, which did not achieve total thrombosis of the pseudoaneurysm.On (b)(6) 2024, a 3mm x 12cm interlock, 3mm x 10cm idc, and 2mm x 4cm idc were placed endovascularly at the origin of the left gastric artery, which provided irrigation to the left gastric artery.On (b)(6) 2024, a ct scan was performed due to rebleeding and low hemoglobin levels, finding a permeable pseudoaneurysm after occlusion of the nourishing artery with the bsc three coils.On (b)(6) 2024, based on the tomography findings, the physician decided to place additional non-boston scientific coils.A repeat control at 15 minutes showed no visualized flow distal to the coils inside the left gastric artery.On the next day, an abdominal and transesophageal ultrasound were performed.The pseudoaneurysm was observed with hypoechoic content, and no saturation on application of color doppler.
Additional Manufacturer Narrative
Corrected h6: patient codes: removed pseudoaneurysm.Correction to field h6: impact codes from serious injury/ illness/ impairment to inadequate/inappropriate treatment or diagnostic exposure.
Event or Problem Description
It was reported that the patient experienced rebleeding and low hemoglobin levels.The patient presented with a history of pancreatitis, which led to active bleeding.The preferred treatment for this condition is to occlude the pseudoaneurysm using an interventional procedure.On (b)(6) 2024, a non-boston scientific (bsc) coil was placed percutaneously inside the pseudoaneurysm.On (b)(6) 2024, a computed tomography (ct) scan documented that the pseudoaneurysm remains permeable.This is likely due to the use of a single coil, which did not achieve total thrombosis of the pseudoaneurysm.On (b)(6) 2024, a 3mm x 12cm interlock, 3mm x 10cm idc, and 2mm x 4cm idc were placed endovascularly at the origin of the left gastric artery, which provided irrigation to the left gastric artery.On (b)(6) 2024, a ct scan was performed due to rebleeding and low hemoglobin levels, finding a permeable pseudoaneurysm after occlusion of the nourishing artery with the bsc three coils.On (b)(6) 2024, based on the tomography findings, the physician decided to place additional non-boston scientific coils.A repeat control at 15 minutes showed no visualized flow distal to the coils inside the left gastric artery.On the next day, an abdominal and transesophageal ultrasound were performed.The pseudoaneurysm was observed with hypoechoic content, and no saturation on application of color doppler.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20346310
• Report Number: 2124215-2024-60160
• Device Sequence Number: 8062247
• Product Code: KRD
• UDI-Device Identifier: 08714729158721
• UDI-Public: 08714729158721
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K141378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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 Expiration Date: 12/17/2025
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0030864653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/29/2024
• Date Device Manufactured: 01/17/2023
• 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: Other
• Patient Age: 32 YR
• Patient Sex: Male