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

Model Number	M00555510
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: an eus fna needle was received by boston scientific.Analysis of the returned device revealed that the distal needle section was broken, additionally, the portion broken was not returned for analysis.No other issues were noted.The distal section of the needle had evidence of bending.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Based on the information available and the analysis performed, the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used during an echo endo puncture procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when he deployed the device, the needle did not go straight normally.The procedure was completed with an acquire needle.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that one portion of the needle was returned broken.
Additional Manufacturer Narrative
Block h6: device problem code 2907 captures the investigation analysis of the tip of the needle broken.Block h10: investigation results an eus fna needle was received by boston scientific.Analysis of the returned device revealed that the distal needle section was broken, additionally, the portion broken was not returned for analysis.No other issues were noted.The distal section of the needle had evidence of bending.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Based on the information available and the analysis performed, the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Block h11: correction to add labeling review to the investigation results.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used during an echo endo puncture procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when he deployed the device, the needle didnt go straight as normally.The procedure was completed with an acquire 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: 10251661
• Report Number: 3005099803-2020-02473
• Device Sequence Number: 2678883
• Product Code: ODG
• UDI-Device Identifier: 08714729848158
• UDI-Public: 08714729848158
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 10/30/2022
• Device Model Number: M00555510
• Device Catalogue Number: 5551
• Device Lot Number: 0024692290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1