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

Model Number	M00547020
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, there was very strong resistance when the balloon was inserted into the bile duct.The balloon could be inflated without any problem, but could not be deflated, so it was removed from the bile duct by force.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.Block h10: investigation results.The returned extractor pro rx retrieval balloon was analyzed, and a microscopic and functional inspection found the balloon was not capable of being inflated and deflated due to it was occluded most likely with dry contrast media, to remove the dry contrast media the device was submerged in warm water, and then the device was inspected again but the problem remained.A wire was introduced to see where the device was occluded and then cutting specifically in that location and after the destructive inspection, it was observed that the catheter has a lump of contrast media restricting the capability of the device to have its functionality tested.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon failure to deflate was unable to be confirmed.The results of the analysis performed on the returned device found some dry contrast media inside the catheter and the balloon, restricting the capability of the device to have its functionality tested.Therefore, the most probable root cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, there was very strong resistance when the balloon was inserted into the bile duct.The balloon could be inflated without any problem, but could not be deflated, so it was removed from the bile duct by force.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18937732
• Report Number: 3005099803-2024-01073
• Device Sequence Number: 15196315
• Product Code: FGE
• UDI-Device Identifier: 08714729790310
• UDI-Public: 08714729790310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/15/2024

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: 01/31/2025
• Device Model Number: M00547020
• Device Catalogue Number: 4702
• Device Lot Number: 0030964298
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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