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

Model Number	M00547010
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that the an extractor pro rx retrieval balloon was used during an endoscopic extraction of biliary stones procedure performed on (b)(6) 2022.During preparation, it was noticed that the balloon did not inflate.The procedure could not be completed as the customer did not have a substitute device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used during an endoscopic extraction of biliary stones procedure performed on (b)(6) 2022.During preparation, it was noticed that the balloon did not inflate.The procedure could not be completed as the customer did not have a substitute device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: investigation results: the returned extractor pro xl retrieval balloon was analyzed, and a visual examination of the catheter found that the guidewire lumen was ripped, and the balloon had no damage.Additionally, the stopcock was found broken.Functional analysis was performed, and the balloon was inflated with air; however, the balloon did not hold the pressure due to the ripped catheter.Microscopic analysis was performed and confirmed that the guidewire lumen ripped on the catheter of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of unable to inflate was confirmed.The ripped catheter is likely to have occurred due result of the use of the guidewire.It's probable that the way that user manipulated the guidewire inside of the shaft and the external pressure applied on the catheter during the preparation induce to the problem found, demonstrating excessive force during usage.Excessive force when withdrawing the guide wire without sufficient care could have ripped the catheter during the procedure.Forcing the device against significant resistance could result in device damage 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.

• 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: 15455869
• Report Number: 3005099803-2022-05403
• Device Sequence Number: 6855511
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: 08714729790297
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 06/28/2023

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: 08/31/2022
• Device Model Number: M00547010
• Device Catalogue Number: 4701
• Device Lot Number: 0025939902
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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