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

Model Number	M00547000
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro retrieval balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.During the procedure, the tip of the balloon no longer guided the wire.It was also split at the top.The procedure was completed with another extractor pro retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of tip bent.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro retrieval balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.During the procedure, the tip of the balloon no longer guided the wire.It was also split at the top.The procedure was completed with another extractor pro retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of tip bent.Block h10: investigation results: the returned extractor pro retrieval balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, due to various guidewire tolerances among manufacturers, it is recommended the extractor pro retrieval balloons family of catheters be used with a boston scientific 0.035 in (0.89 mm) guidewire according to ifu.Therefore, the extractor device was loaded using a guidewire (jagwire 0.035).The guidewire was backloaded and exit at the ramp mandrel as is expected; no resistance was felt during the loading.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of tip bent cannot be confirmed.There was no confirmation on what the customer indicated because the guidewire was backloaded and exit at the ramp mandrel as is expected; no resistance was felt during the loading.Also, the device met all the manufacturing requirements, and it passed the visual and functional inspections during the product analysis.Therefore, the most probable root cause is no problem detected.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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17912480
• Report Number: 3005099803-2023-05406
• Device Sequence Number: 20707210
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: 08714729790266
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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: 04/10/2025
• Device Model Number: M00547000
• Device Catalogue Number: 4700
• Device Lot Number: 0031396568
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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