MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ACQUIRETM; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number	M00555560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Fever (1858)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the pancreatic body during an endoscopic ultrasound fine needle biopsy procedure performed on (b)(6) 2017.According to the complainant, the biopsy was performed transgrastrically and the procedure was completed with this device with no patient injury.However, post procedure, it was reported that the patient had developed a pancreatic cyst which is progressing towards recovery due to conservative treatment.The patient's condition after the treatment was reported to be good.
Additional Manufacturer Narrative
Additional information a dhr (device history record) review was performed and no deviation was found.A search of the complaint database revealed that no other complaints exist for the specified lot.A labeling review was performed and there is information to determine that the device was not used in accordance with the labeling.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the pancreatic body during an endoscopic ultrasound fine needle biopsy procedure performed on (b)(6) 2017.According to the complainant, the biopsy was performed transgrastrically and the procedure was completed with this device with no patient injury.However, post procedure, it was reported that the patient had developed a pancreatic cyst which is progressing towards recovery due to conservative treatment.The patient's condition after the treatment was reported to be good.Based on the additional information received on march 17, 2017, it was confirmed that they targeted a tumor at the pancreatic body but it is unknown if the cyst developed at the operative site.On (b)(6) 2017, 10 days after the procedure, the patient developed fever with an increase of c-reactive protein (crp) and biliary tract marker.Ultrasound was taken confirming a pancreatic cyst.As per physician's assessment, the occurrence of the pancreatic cyst is an anticipated complication that could have been caused by the ercp procedure and the usage of this device.Lastly, food and drinks were restricted and the patient was placed under observation.

• Brand Name: ACQUIRETM
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela IN ; CS
• MDR Report Key: 6400957
• Report Number: 3005099803-2017-00834
• Device Sequence Number: 13587480
• Product Code: ODG
• UDI-Device Identifier: 08714729931805
• UDI-Public: (01)08714729931805(17)20181130(10)0019973730
• Combination Product (Y/N): N
• PMA/510(K) Number: K160845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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 Expiration Date: 11/30/2018
• Device Model Number: M00555560
• Device Catalogue Number: 5556
• Device Lot Number: 0019973730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 04/11/2017
• 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: Other