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

Model Number	M00555540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Inflammation (1932)
Date of Event	04/23/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation; 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 acquire needle was used during an endoscopic ultrasound fine needle biopsy procedure performed in the pancreas on (b)(6) 2019.It was reported that the physician performed three passes in the pancreatic head with the needle and was able to obtain adequate sample.The biopsy procedure was completed using this acquire needle.There was no alleged deficiency of the acquire needle reported.Post procedure, the patient experienced pain and remained in the hospital overnight for observation.The next day, on (b)(6) 2019 the patient was diagnosed with pancreatitis.The physician reported that the pancreatitis was likely a result of the biopsy that was performed.The physician also stated that the patient had a history of chronic pancreatitis.The pancreatitis reportedly got worse and the patient was then placed on a ventilator.The patient then developed renal failure and expired on (b)(6) 2019.The physician confirmed that autopsy results will not be made available to boston scientific corporation.The patient reportedly expired on (b)(6) 2019 due to multiple organ failure.

• Brand Name: ACQUIRE
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8700092
• Report Number: 3005099803-2019-02870
• Device Sequence Number: 16602173
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160845
• 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): 06/14/2019

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: Health Professional
• Device Model Number: M00555540
• Device Catalogue Number: 5554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: Death
• Patient Age: 67 YR