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

Model Number	M00547110
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used in the distal common bile duct for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was noticed that the tip of the catheter was kinked.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 xl retrieval balloon was used in the distal common bile duct for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was noticed that the tip of the catheter was kinked.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 result: the returned extractor pro xl retrieval balloon was analyzed, and a visual examination of device found that the balloon and the catheter of device had no damages.Microscopic inspection found the tip of the balloon was bent.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of the balloon tip bent was confirmed.It is possible that factors encountered during the procedure may have caused the balloon tip to bend, such as excess force during device unpacking or during insertion through the scope.Therefore, the most probable root cause is adverse event related to procedure.

• 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: 17283644
• Report Number: 3005099803-2023-03627
• Device Sequence Number: 20387029
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 05/26/2024
• Device Model Number: M00547110
• Device Catalogue Number: 4711
• Device Lot Number: 0029484114
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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 Sex: Unknown