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

Model Number	M00547140
Medical Device Problem Codes	Inflation Problem (1310); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.
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 common bile duct during a common bile duct lithotripsy procedure performed on (b)(6) 2024.During the procedure, after unpacking the device, air was introduced, however, a resistance was felt, and poor deflation was observed.Despite these problems, the device was used continuously.It was then inserted into the common bile duct through an endoscope.When the balloon was inflated, the same problem occurred.The device was removed from the body to have it checked and injected a saline solution into the balloon lumen instead of air, but the problem persisted.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 a140101 captures the reportable event of balloon failure to deflate.Block h10: investigation results: the returned extractor pro xl retrieval balloons was analyzed, and a visual and microscopic inspection found no damages to the device.Functional inspection was performed, and the balloon was able to be inflated and deflated without problem and it was able to hold the pressure without any evidence of a possible leak of air.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 results of the analysis performed on the returned device found that the balloon was in good conditions and with the capability of being inflated, deflated and it was able to hold its 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 xl retrieval balloon was attempted to be used in the common bile duct during a common bile duct lithotripsy procedure performed on (b)(6) 2024.During the procedure, after unpacking the device, air was introduced, however, a resistance was felt, and poor deflation was observed.Despite these problems, the device was used continuously.It was then inserted into the common bile duct through an endoscope.When the balloon was inflated, the same problem occurred.The device was removed from the body to have it checked and injected a saline solution into the balloon lumen instead of air, but the problem persisted.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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19042814
• Report Number: 3005099803-2024-01461
• Device Sequence Number: 17959675
• Product Code: FGE
• UDI-Device Identifier: 08714729790365
• UDI-Public: 08714729790365
• 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): 05/06/2024

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: 11/28/2025
• Device Model Number: M00547140
• Device Catalogue Number: 4714
• Device Lot Number: 0032950036
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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