MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER EXPECT¿; BIOPSY NEEDLE KIT

Model Number	M00550010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/25/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect¿ needle device was used in the tail of pancreas during an endoscopic ultrasound fine needle aspiration (eus fna) procedure performed on (b)(6) 2014 as part of the e7084 eus fna cystic lesions clinical study.The patient had a history of diabetes.The patient¿s pancreatic cystic lesion (pcl) was located in the tail of the pancreas and was not symptomatic.The pcl was unilocular and had a maximal diameter of 15mm and a perpendicular measurement of 12mm.The pcl was connected to the pancreatic duct.There were no solid components, no presence of visible mucin, and no distinct pcl wall.The maximal pancreatic duct diameter size was 23mm and a mural nodule was not present.On (b)(6) 2014, the patient underwent eus fna.Prophylactic antibiotics were given and the route of access of the echoendoscope was gastric.During the procedure, the pcl could be reached and penetrated.One pass was attempted and was successful, and no salvage procedure was required.The total volume of aspirate was 2ml.The aspirate¿s viscosity was like water, the clarity was clear, the color was transparent.Per the eus fna, the disease was determined to be intraductal papillary mucinous neoplasm (ipmn).On (b)(6) 2014, the patient presented with acute pancreatitis and was admitted to the hospital.The patient was discharged on (b)(6) 2014.According to the physician, the patient had undergone a separate fna from a transitional zone in the main pancreatic duct of the pancreas.Per the physician, fnas of the main duct carry higher risk of pancreatitis.Therefore, the physician was unable to determine with 100% certainty whether the pancreatitis was due to the cyst fna with the expect needle or due to the other fna of the main duct.

• Brand Name: EXPECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7446925
• Report Number: 3005099803-2018-01190
• Device Sequence Number: 2052994
• Product Code: FCG
• UDI-Device Identifier: 08714729790044
• UDI-Public: 08714729790044
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K100712
• 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): 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 09/25/2016
• Device Model Number: M00550010
• Device Catalogue Number: 5001
• Device Lot Number: 16413340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR