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	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of balloon irregular shape.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was attempted to be used during a procedure performed on (b)(6) 2024.During the procedure, the balloon did not fully inflate.From its center part, only one side of the balloon inflated making it unusable.The procedure was completed with another extractor pro xl retrieval balloon.No further information has been obtained despite good faith efforts.The reported event may suggest that the balloon inflated to an irregular shape.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was attempted to be used during a procedure performed on (b)(6) 2024.During the procedure, the balloon did not fully inflate.From its center part, only one side of the balloon inflated making it unusable.The procedure was completed with another extractor pro xl retrieval balloon.No further information has been obtained despite good faith efforts.The reported event may suggest that the balloon inflated to an irregular shape.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 irregular shape.Block h11: investigation results: the returned extractor pro xl retrieval balloon was analyzed, and a visual and microscopic evaluation 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.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon irregular shape was unable to be confirmed.The returned device was inspected, and functional testing found the balloon in good condition and with the capability of being inflated and holding pressure without any evidence of an air leak or irregular shape.Therefore, the most probable root cause is no problem detected.

• 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: 20696102
• Report Number: 3005099803-2024-05749
• Device Sequence Number: 17072445
• Product Code: FGE
• UDI-Device Identifier: 08714729790648
• UDI-Public: 08714729790648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/11/2024

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: 05/21/2026
• Device Model Number: M00547120
• Device Catalogue Number: M00547120
• Device Lot Number: 0034073174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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