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

Model Number M00555540

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Inflammation (1932)

Event Date 04/23/2019

Event Type  Death  

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 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
• Type of Device: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; ,; spencer IN 47460
• Manufacturer Contact: carole morley ; 100 boston scientific way; ,; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 8700092
• MDR Text Key: 148027747
• Report Number: 3005099803-2019-02870
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00555540
• Device Catalogue Number: 5554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR