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 Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
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 on (b)(6) 2020.According to the complainant, prior to the device packaging being opened, a hair was noticed from the outside of the packaging.It was noted that there was no physical damage on the packaging.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 2969 captures the reportable issue of foreign matter.Block h10: investigation results visual examination of the complaint device found that the there was a hair was inside of the original unopened pouch, thereby confirming the reported event.The most probable root cause is manufacturing deficiency, as the reported failure was traced to the manufacturing process.An investigation to address this issue 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.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was unpacked for a procedure on (b)(6) 2020.According to the complainant, prior to the device packaging being opened, a hair was noticed from the outside of the packaging.It was noted that there was no physical damage on the packaging.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
• MDR Report Key: 10251705
• Report Number: 3005099803-2020-02603
• Device Sequence Number: 19502787
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: 03/02/2022
• Device Model Number: M00547140
• Device Catalogue Number: 4714
• Device Lot Number: 0025288678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1