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

Model Number	M00547000
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the common bile duct (cbd) for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation outside the patient, the balloon would not come out of the blue catheter.The user tugged harder and broke the balloon catheter into two separate pieces.Another device was opened, and the procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Block h10: investigation results: the returned extractor pro rx retrieval balloon was analyzed, and a visual examination found that the catheter of the device was returned in two separate sections and was found damaged (ripped) and stretched.No damages were noted to the balloon portion of the device.Microscopic inspection was performed, and the catheter was found to be damaged (ripped) and stretched.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter break was confirmed as the catheter was returned in two separate sections.The catheter was damaged (ripped) and stretched which occurred likely due to the manner in which the device was handled and manipulated.Excessive manipulation of the device without enough care, excessive force during handling or usage, and/or forcing the device against significant resistance could induce device damages or loss of functionality.Therefore, the most probable root cause is adverse event related to procedure.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 rx retrieval balloon was used in the common bile duct (cbd) for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation outside the patient, the balloon would not come out of the blue catheter.The user tugged harder and broke the balloon catheter into two separate pieces.Another device was opened, and the procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16592594
• Report Number: 3005099803-2023-01485
• Device Sequence Number: 19541669
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: 08714729790266
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/24/2023

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: 01/29/2025
• Device Model Number: M00547000
• Device Catalogue Number: 4700
• Device Lot Number: 0030945025
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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