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

Model Number	M00555510
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18 (b)(4).Visual evaluation revealed that the needle and sheath was kinked near the handle.It was also noted the distal end of the needle was slightly bent.In addition the needle punctured through the sheath and the distal tip was barbed.Functional analysis revealed that the needle unable to extend and retract but the needle was forcibly extended.Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.  a review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no other complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that an expect¿ slimline needle was used in the duodenum during an endoscopic ultrasound (eus) on (b)(6) 2017.According to the complainant, during the procedure, the needle was stuck and was unable to extend out of the catheter.Another of the same device was used to complete the case.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.The investigation found that the needle punctured the sheath, this is now deemed an mdr reportable event.

• Brand Name: EXPECT¿ SLIMLINE (SL)
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7037131
• Report Number: 3005099803-2017-03487
• Device Sequence Number: 13684789
• Product Code: ODG
• UDI-Device Identifier: 08714729848158
• UDI-Public: 08714729848158
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K133312
• 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
• Report Date (Section B): 10/23/2017

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: 01/31/2020
• Device Model Number: M00555510
• Device Catalogue Number: 5551
• Device Lot Number: 20141176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1