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

Model Number	M00547100
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was being prepared for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stone to be performed on (b)(6) 2025.During preparation, it was noticed that the packaging seal was damaged and compromised.There was no device malfunction noted.Additionally, a photo of the packaging was provided and showed that the sterile packaging seal was not sealed.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.Block h11: investigation results- the returned extractor pro xl retrieval balloon was analyzed, and a visual inspection found no damages to the device, regarding of the packaging, it was returned opened and a sign of seal evidence is clearly visible.Media analysis was performed, where it can be observed the opened packaging.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of packaging seal compromised was confirmed.Although the packaging was found open, the presence of sealing marks indicates that the package had previously been sealed correctly.This suggests that the opening occurred due to external factors such as transport or storage conditions rather than a manufacturing defect.As a result, there is no evidence to support a packaging failure attributable to the manufacturing process.These problems could be caused due to environmental factors during the transport or storage of the device, also an incorrect storage, without the proper conditions could have induced the analyzed defects.The investigation findings and all information available concludes the most probable root cause is cause traced to transport/storage.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was being prepared for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stone to be performed on (b)(6) 2025.During preparation, it was noticed that the packaging seal was damaged and compromised.There was no device malfunction noted.Additionally, a photo of the packaging was provided and showed that the sterile packaging seal was not sealed.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23433217
• Report Number: 3005099803-2025-05777
• Device Sequence Number: 4732818
• Product Code: FGE
• UDI-Device Identifier: 08714729790389
• UDI-Public: (01)08714729790389(17)261209(10)35447785
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/13/2026

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 Model Number: M00547100
• Device Catalogue Number: M00547100
• Device Lot Number: 0035447785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 52 KG