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

Model Number	M00555510
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline 22g eus needle was used in the pancreas during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the needle was removed from the scope, after the third sample was taken.When the needle was outside of the scope, it was noticed that the distal tip of the needle was broken.The needle was reported broken approximately 5 cm from the distal tip.Nothing reportedly detached inside of the patient.The procedure was completed with another expect slimline needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g2: literature source.Journal article: kim, kook & kim, sung & kim, tae.(2020).Needle fracture, a rare endoscopic ultrasound-guided fine needle aspiration complication and why?.Clinical endoscopy.54.10.5946/ce.2020.128.Block h2: additional information block a2 (patient age), a3 (patient sex), b5 (event description), g2 (report source) and h6 (impact codes) have been updated based on the additional information received on february 8, 2024.Block h6: device code 2907 captures the reportable event of needle detached.Block h10: 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline 22g eus needle was used in the pancreas during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the needle was removed from the scope, after the third sample was taken.When the needle was outside of the scope, it was noticed that the distal tip of the needle was broken.The needle was reported broken approximately 5 cm from the distal tip.Nothing reportedly detached inside of the patient.The procedure was completed with another expect slimline needle.There were no patient complications reported as a result of this event.Additional information received on february 8, 2024.Boston scientific corporation became aware of an article in which an event, previously assessed, is reported.The event is being highlighted once again through the article: "needle fracture, a rare endoscopic ultrasound-guided fine-needle aspiration complication and why?." clinical endoscopy (2021).By kim et al.Per the article, the expect needle was used to acquire tissue in the duodenum, not the pancreas.During the third pass, the endoscope suddenly pushed back into the stomach and the needle tip wedged in the duodenal mass.The needle was slipped back into the sheath with a forceful pull and without any complications.A fragment of the detached needle dropped into the saline tube when the aspirated sample was being removed.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10064998
• Report Number: 3005099803-2020-01955
• Device Sequence Number: 11700555
• Product Code: ODG
• UDI-Device Identifier: 08714729848158
• UDI-Public: 08714729848158
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: 08/05/2022
• Device Model Number: M00555510
• Device Catalogue Number: 5551
• Device Lot Number: 0024220049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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: 77 YR
• Patient Sex: Male