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

Model Number	M00547120
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of balloon deformed.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.It was reported that the size of the balloon and the shape was not normal.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of balloon deformed.Block h11: investigation results: the returned extractor pro xl retrieval balloon was analyzed, and a visual and microscopic inspection noted no damages to the device.Functional testing was performed, and the balloon was able to be inflated, held pressure, and formed a normal shape without any evidence of a possible leak.Dimensional inspection was performed, and the balloon concentricity was measured and confirmed that it is within specification.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon irregular shape was unable to be confirmed.The returned device was inspected, and functional testing found the balloon was able to inflate and deflate without any problem.Also, the balloon has a form and concentricity according to the specification.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.It was reported that the size of the balloon and the shape was not normal.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 19043042
• Report Number: 3005099803-2024-01486
• Device Sequence Number: 7355063
• Product Code: FGE
• UDI-Device Identifier: 08714729790648
• UDI-Public: 08714729790648
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 06/15/2025
• Device Model Number: M00547120
• Device Catalogue Number: 4712
• Device Lot Number: 0031834519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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
• Patient Sex: Unknown