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

Model Number	M00547050
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was being prepared for use in the central bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed on (b)(6) 2024.During preparation, the balloon was attempted to be inflated, as it usually expands by being pushed to the 15 mm position.However, this time it did not inflate at the 15 mm position.Therefore, it was pushed up to 18 mm and then pulled back to the 15 mm position to adjust its size.Unfortunately, the shape of the balloon was distorted during the process.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
H6: imdrf device code a0406 captures the reportable event of irregular shaped balloon.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was being prepared for use in the central bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed on (b)(6) 2024.During preparation, the balloon was attempted to be inflated, as it usually expands by being pushed to the 15 mm position.However, this time it did not inflate at the 15 mm position.Therefore, it was pushed up to 18 mm and then pulled back to the 15 mm position to adjust its size.Unfortunately, the shape of the balloon was distorted during the process.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 a0406 captures the reportable event of irregular shaped balloon.Block h10: investigation results the returned extractor pro rx retrieval balloon was analyzed, and a visual examination found no damages to the device.Also, a functional test was performed on the device, and the balloon was able to be inflated and maintain its air pressure without any problem and no irregular shapes were found.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of irregular shape was not confirmed.The results of the analysis performed on the returned device found the device returned with the balloon in good condition and with the capability of being inflated and hold its pressure without any evidence of an air leak.Also, no shape problems on the balloon were found.Therefore, the most probable root cause is no problem detected.

• 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: 18610489
• Report Number: 3005099803-2024-00201
• Device Sequence Number: 2441313
• Product Code: FGE
• UDI-Device Identifier: 08714729790303
• UDI-Public: 08714729790303
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 10/17/2025
• Device Model Number: M00547050
• Device Catalogue Number: 4705
• Device Lot Number: 0032662809
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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