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

Model Number	M00547150
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reported city: (b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used in the common bile duct for a biliary lithotomy for gallstone removal procedure performed on (b)(6) 2023.During the procedure, the balloon was able to be inflated but the balloon could not deflate.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications 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 used in the common bile duct for a biliary lithotomy for gallstone removal procedure performed on january 05, 2023.During the procedure, the balloon was able to be inflated but the balloon could not deflate.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reported city: (b)(6).Block h6: imdrf device code a140101 captures the reportable event of balloon could not deflated.Block h10: investigation results- the returned extractor pro rx retrieval balloon was analyzed and a visual examination found no damages to the catheter or balloon.Functional analysis was performed and the balloon was inflated without a problem, held pressure and deflated correctly.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon could not deflate was not confirmed.No damages were found on the returned balloon, and it inflated and deflated properly during functional testing.Therefore, the most probable root cause is no problem detected.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16240332
• Report Number: 3005099803-2023-00202
• Device Sequence Number: 6605533
• Product Code: FGE
• UDI-Device Identifier: 08714729790372
• UDI-Public: 08714729790372
• 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): 02/22/2023

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: 05/02/2024
• Device Model Number: M00547150
• Device Catalogue Number: 4715
• Device Lot Number: 0029326886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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