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

Model Number	M00547140
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of device contaminated during manufacture or shipping.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was received by the customer on (b)(6) 2025.Before the procedure, upon receiving the package, a hair was found in the sealed packaging of the product.A photo of the device packaging was submitted by the customer and showed a hair inside the sealed package.The product was not used in a procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of device contaminated during manufacture or shipping.Block h11: investigation results- the returned extractor pro xl retrieval balloon was analyzed, and a visual and media inspection found a hair secured in the seal of the back plastic film.A microscopic evaluation found the hair is unable to be dislodged since the plastic film cannot be lifted.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of packaging foreign matter was confirmed.The returned device with its original pouch unopened shows a hair that is secured in the seal of the back plastic film (brochure envelope).The hair is unable to be dislodged since the plastic film cannot be lifted.Also, a photo of the device packaging was submitted by the customer which showed a hair secured in the seal of the back plastic film.The brochure envelope is manually applied to the exterior of an empty pouch.Since both components are flexible polymer packaging, there may be minor gaps along the perimeter if an envelope does not entirely seal.Foreign matter can become lodged in these gaps, and when external pressure is applied during handling, transportation, and storage, this foreign matter can get trapped by the seal.Therefore, the most probable root cause is quality control deficiency.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was received by the customer on (b)(6) 2025.Before the procedure, upon receiving the package, a hair was found in the sealed packaging of the product.A photo of the device packaging was submitted by the customer and showed a hair inside the sealed package.The product was not used in a procedure.There were no patient complications reported as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21454726
• Report Number: 3005099803-2025-00635
• Device Sequence Number: 17320408
• Product Code: FGE
• UDI-Device Identifier: 08714729790365
• UDI-Public: (01)08714729790365(17)261031(10)35186115
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: M00547140
• Device Catalogue Number: M00547140
• Device Lot Number: 0035186115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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 Sex: Unknown