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

Model Number	M00555500
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results of needle punctured the sheath.A visual evaluation of the returned device found the working length of the needle and sheath were kinked near the distal end of the handle.The distal tip of the needle had punctured through the sheath which caused the bending of the needle tip.Functional evaluation was performed, resistance was met when the needle was extended, however the needle was able to extend with force.The needle adjust and length adjust knobs presented no issues.Marks were visible at the handle and needle adjusting shaft which indicates the knobs locking and unlocking during the procedure.The reported event was confirmed.Based on all gathered information, anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure 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¿ needle device was used in the pancreatic during an endoscopic ultrasound fine needle aspiration (eus fna) procedure performed on unknown date.According to the complainant, during the procedure the complainant reported the needle was unable to advance and adjust the handle.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 through the sheath and the distal tip was bent, 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: 6372818
• Report Number: 3005099803-2017-00525
• Device Sequence Number: 395176
• Product Code: ODG
• UDI-Device Identifier: 08714729848141
• UDI-Public: (01)08714729848141(17)20190930(10)19735471
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K133312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2017

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: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: M00555500
• Device Catalogue Number: 5550
• Device Lot Number: 19735471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 03/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1