MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY PRO; CATHETER, PERCUTANEOUS

Model Number	8101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, it was confirmed rgar the returned product was damaged.Upon visual inspection it was observed that the shaft was cut all the way down from the procedure with numerous kinks.The shaft was detached from the hub.The separated ends were damaged with braiding exposed, indicating there was trouble cutting the device.Moreover, the most probable cause for this complaint was considered unintended use error caused or contributed to event.The investigation concluded code was utilized for the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.
Event or Problem Description
It was reported that this product was returned with no reported product performance issues and no reported adverse patient effects.Initial analysis completed in our post market quality assurance laboratory identified a product performance issue.

• Brand Name: ACUITY PRO
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8872348
• Report Number: 2124215-2019-17071
• Device Sequence Number: 3079397
• Product Code: DQY
• UDI-Device Identifier: 08714729932468
• UDI-Public: 08714729932468
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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: 04/18/2020
• Device Model Number: 8101
• Device Catalogue Number: 8101
• Device Lot Number: 22010686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1