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

Model Number	M00547110
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 xl retrieval balloon was used in the biliary tract for an endoscopic retrograde cholangiopancreatography (ercp) procedure with lithotripsy performed on (b)(6) 2023.During the procedure, after performing the exchange step to leave the guidewire in the biliary tract and pass the balloon extractor, the device advanced over the guidewire, entered the biliary tract and was insufflated.Calculi was extracted and the balloon would not deflate when re-entering the biliary tract.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.The customer provided a video of the device being used outside the patient.The video shows the balloon inflates correctly but, does not deflate.
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failed to deflate.Block h10: investigation results the returned extractor pro xl 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.Microscopic analysis of the stopcock found residues of water inside it.Media inspection of the video provided by the customer found it was possible to observe that the balloon did not deflate.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 confirmed.There is evidence in the video attached by the customer that the balloon could not deflate.However, that was not functionally/visually verified with the device returned.Since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event, cause not established is selected as the most probable cause for the event.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used in the biliary tract for an endoscopic retrograde cholangiopancreatography (ercp) procedure with lithotripsy performed on (b)(6) 2023.During the procedure, after performing the exchange step to leave the guidewire in the biliary tract and pass the balloon extractor, the device advanced over the guidewire, entered the biliary tract and was insufflated.Calculi was extracted and the balloon would not deflate when re-entering the biliary tract.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: the customer provided a video of the device being used outside the patient.The video shows the balloon inflates correctly but, does not deflate.

• 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: 16386615
• Report Number: 3005099803-2023-00701
• Device Sequence Number: 14831433
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/14/2023

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: 06/08/2024
• Device Model Number: M00547110
• Device Catalogue Number: 4711
• Device Lot Number: 0029558446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 52 KG