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

Model Number	M00547000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon catheter tip detached.
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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was difficult to feed the balloon catheter through the autocap locking device, causing the catheter to kink during the surgery.Additionally, it was quite challenging to get the guidewire to go into and out of the duct and the distal part of the balloon.The user switched to another of the same balloon and discovered that the tip of the balloon was protruding from the ampulla as it was pushed out of the scope.The distal tip at the radiopaque (ro) marker detached from the device inside the patient.After removing the remaining balloon device from the patient, the physician was able to pull out the broken tip with rat tooth forceps.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications as a result of this event.Note: the customer provided a photo of the device.The photo shows the tip of the balloon detached inside the patient anatomy.
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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was difficult to feed the balloon catheter through the autocap locking device, causing the catheter to kink during the surgery.Additionally, it was quite challenging to get the guidewire to go into and out of the duct and the distal part of the balloon.The user switched to another of the same balloon and discovered that the tip of the balloon was protruding from the ampulla as it was pushed out of the scope.The distal tip at the radiopaque (ro) marker detached from the device inside the patient.After removing the remaining balloon device from the patient, the physician was able to pull out the broken tip with rat tooth forceps.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications as a result of this event.Note: the customer provided a photo of the device.The photo shows the tip of the balloon detached inside the patient anatomy.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon catheter tip detached.Block h10: investigation results: the returned extractor pro rx retrieval balloon was analyzed, and a visual examination found that the distal tip of the balloon is detached from the catheter.Media analysis was performed, it was observed that the tip of the balloon detached.Microscopic analysis was performed, the catheter of the balloon is kinked, and rx channel is jammed.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of tip detachment was confirmed.It was found that the distal tip of the balloon was detached from the catheter, the catheter was kinked, and the rx channel was jammed.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.Also, anatomical conditions could have interfered in the device performance or the procedure outcome.Therefore, the most probable root cause is adverse event related to procedure.

• 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: carol morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17357052
• Report Number: 3005099803-2023-03816
• Device Sequence Number: 5227627
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: 08714729790266
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2025
• Device Model Number: M00547000
• Device Catalogue Number: 4700
• Device Lot Number: 0031551972
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown