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

Model Number	M00555521
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect¿ slimline needle was opened on an unknown date.According to the complainant, one of the expect¿ needle devices from a box of five was opened and it was noticed that the handle and needle were sticking outside the packaging rendering the sterile barrier to be compromised.There was no procedure nor patient involvement.
Additional Manufacturer Narrative
Investigation results: a visual evaluation of the returned expect¿ needle device revealed that the pouch was partially opened and the device was sticking out of the package.Additionally, evidence of heat seal runs throughout the entire width of the pouch without any breaks.The complaint was confirmed.Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined, therefore, the root cause classification is undeterminable.The review and analysis of all available information fails to indicate a root cause or probable root cause for the reported event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.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 opened on an unknown date.According to the complainant, one of the expect¿ needle devices from a box of five was opened and it was noticed that the handle and needle were sticking outside the packaging rendering the sterile barrier to be compromised.There was no procedure nor patient involvement.

• 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: 6214965
• Report Number: 3005099803-2016-04065
• Device Sequence Number: 10985678
• Product Code: ODG
• UDI-Device Identifier: 08714729848738
• UDI-Public: (01)08714729848738(17)20191031(10)19850813
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2016

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: 10/31/2019
• Device Model Number: M00555521
• Device Lot Number: 19850813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2016
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1