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

Model Number	M00547000
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1401 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 in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2024.During the procedure, the balloon would not inflate on initial attempt.Upon eventual inflation, the balloon would not deflate after several attempts and removal of inflation syringe.The balloon was partially deflated before removing out of the patient or scope.The procedure was completed with a larger extractor pro retrieval balloon (12 mm -15 mm).There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1401 captures the reportable event of balloon failed to deflate.Block h11: investigation results: the returned extractor pro retrieval balloon was analyzed, and a visual inspection found no damages to the device.Functional inspection was performed, and the balloon was able to be inflated/deflated and held pressure without any evidence of a leak.Dimensional inspection was performed, and the outer diameter of the catheter was measured in three sections.All measurements were within the specification.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 no visible damages to the device and the balloon was able to be inflated/deflated without problem and held the pressure without any evidence of a leak.Also, the outer diameter of the catheter measurements were within the specification.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 in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2024.During the procedure, the balloon would not inflate on initial attempt.Upon eventual inflation, the balloon would not deflate after several attempts and removal of inflation syringe.The balloon was partially deflated before removing out of the patient or scope.The procedure was completed with a larger extractor pro retrieval balloon (12 mm -15 mm).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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19909674
• Report Number: 3005099803-2024-03635
• Device Sequence Number: 8752063
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: 08714729790266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 05/03/2026
• Device Model Number: M00547000
• Device Catalogue Number: 4700
• Device Lot Number: 0033957790
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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 Age: 66 YR
• Patient Sex: Male