MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT SLIMLINE (SL); ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number	M00555511
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used in the pancreas during an endoscopic ultrasound-guided fine needle aspiration (eus fna) procedure performed on (b)(6) 2021.During the procedure, the needle broke off at the distal end after the third pass while sampling a calcified pancreatic mass.The needle tip (2cm) was removed from the patient using forceps with an overtube.The procedure was completed with another expect slimline needle.There were no patient complications reported as a result of this event.

• Brand Name: EXPECT SLIMLINE (SL)
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11825006
• Report Number: 3005099803-2021-02223
• Device Sequence Number: 19120879
• Product Code: ODG
• UDI-Device Identifier: 08714729848721
• UDI-Public: 08714729848721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K163058
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2023
• Device Model Number: M00555511
• Device Catalogue Number: 50262
• Device Lot Number: 0026017795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention