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

Model Number	M00547010
Medical Device Problem Codes	Crack (1135); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failed to deflate.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was attempted to be used during a procedure performed on (b)(6) 2024.During the procedure, a catheter crack was noted on the channel level at the time of inflating the balloon.Thereafter, the device could not be deflated.The procedure was completed with another extractor pro rx retrieval balloon.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failed to deflate.Block h11: (investigation results) the returned extractor pro rx retrieval balloon was analyzed, and a visual and microscopic evaluation noted no damages to the device.The catheter also has no visible problem.Additionally, functional evaluation revealed that the balloon was able to be inflated and deflated.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon failure to deflate was not confirmed.The returned device was found to have no visible physical damages.The balloon was able to be inflated and deflated without any problem.The balloon was also able to hold pressure without any evidence of an air leak.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 rx retrieval balloon was attempted to be used during a procedure performed on (b)(6) 2024.During the procedure, a catheter crack was noted on the channel level at the time of inflating the balloon.Thereafter, the device could not be deflated.The procedure was completed with another extractor pro rx retrieval balloon.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.

• Brand Name: EXTRACTOR PRO RX
• 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: 21016457
• Report Number: 3005099803-2024-06533
• Device Sequence Number: 6780706
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: 08714729790297
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 09/03/2025
• Device Model Number: M00547010
• Device Catalogue Number: M00547010
• Device Lot Number: 0032349780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 12/25/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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
• Patient Sex: Unknown