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	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro retrieval balloon was used in the common bile duct (cbd) during a gallstone removal procedure performed on (b)(6), 2022.During the procedure, it was noticed that the balloon could be inflated; however, it would not deflate.The procedure was completed with another extractor pro retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a140101 captures the reportable issue of balloon failed to deflate.Block h10: investigation results.The returned extractor pro retrieval balloon was analyzed and a visual examination found the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated to the recommended inflation volumes without issue.There were no leaks, holes or pinholes noted in the balloon and the balloon was able to hold pressure.It was also noted that the balloon was able to deflate without issue.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon failure to deflate cannot be confirmed.No damages were found on the returned balloon and it inflated, held pressure, and deflated properly during functional testing.Therefore, the most probable root cause cannot be determined as no problem was detected.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro retrieval balloon was used in the common bile duct (cbd) during a gallstone removal procedure performed on (b)(6) 2022.During the procedure, it was noticed that the balloon could be inflated; however, it would not deflate.The procedure was completed with another extractor pro 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16152745
• Report Number: 3005099803-2022-08040
• Device Sequence Number: 20577195
• 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: 09/01/2024
• Device Model Number: M00547150
• Device Catalogue Number: 4715
• Device Lot Number: 0030074679
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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