MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO XL; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547120
Medical Device Problem Codes	Defective Device (2588); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Biliary Leak (4820)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During a cholangiogram procedure to help locate a blockage in the bile duct, a stone extraction balloon was inflated and there was "an injury or leak in the bile duct." a stent was placed in the bile duct.The patient was treated with antibiotic therapy and hospitalized.No further information has been obtained despite good-faith efforts.The specific device problem is unknown.It was reported that "the device did not do what it was supposed to do.".
Additional Manufacturer Narrative
User facility reference number: (b)(4).Imdrf patient code e1108 is being used to capture the reportable event of biliary leak.Imdrf impact code f08 is being used to capture the reportable event of prolonged hospitalization.Imdrf impact code f2301 is being used to capture the reportable event of additional device required.Imdrf impact code f2303 is being used to capture the reportable event of medication required.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During a cholangiogram procedure to help locate a blockage in the bile duct, a stone extraction balloon was inflated and there was "an injury or leak in the bile duct." a stent was placed in the bile duct.The patient was treated with antibiotic therapy and hospitalized.No further information has been obtained despite good-faith efforts.The specific device problem is unknown.It was reported that "the device did not do what it was supposed to do." additional information received on june 21, 2024: additional information was received that this event was previously reported.See mfr.Report #3005099803-2024-00803.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem) and block h10 have been updated.Block h6: imdrf patient code e1108 is being used to capture the reportable event of biliary leak.Imdrf impact code f08 is being used to capture the reportable event of prolonged hospitalization.Imdrf impact code f2301 is being used to capture the reportable event of additional device required.Imdrf impact code f2303 is being used to capture the reportable event of medication required.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19233391
• Report Number: 3005099803-2024-01958
• Device Sequence Number: 17559073
• Product Code: FGE
• UDI-Device Identifier: 08714729790648
• UDI-Public: 08714729790648
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K102082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2025
• Device Model Number: M00547120
• Device Catalogue Number: 4712
• Device Lot Number: 0032151609
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown