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

Model Number	M00547140
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was unpacked for a procedure performed on (b)(6) 2021.A 3-4mm pink thread/string was noticed in the sealed portion of the sterilization bag.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was unpacked for a procedure performed on (b)(6) 2021.A 3-4mm pink thread/string was noticed in the sealed portion of the sterilization bag.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: problem code a180104 captures the reportable event of foreign material.Block h10: investigation results a visual examination of the returned complaint device found a foreign material inside of the original unopened pouch.Microscopic analysis was performed and it was confirmed that the diameter of the foreign matter was between 3 to 4 mm, thereby confirming the reported event.The most probable root cause is manufacturing deficiency, as the reported event was traced to the manufacturing process.An investigation to address this problem has been completed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11622122
• Report Number: 3005099803-2021-01450
• Device Sequence Number: 19604462
• Product Code: FGE
• UDI-Device Identifier: 08714729790365
• UDI-Public: 08714729790365
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 12/14/2022
• Device Model Number: M00547140
• Device Catalogue Number: 4714
• Device Lot Number: 0026512369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/24/2021
• Patient Sequence Number: 1