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

Model Number	8105
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a lead implant procedure, it was evident through contrast that a very small perforation had occurred in the coronary sinus when the catheter was inserted.The contrast medium dissipated by the end of the procedure and the physician stated that no further action was needed.The patient was stable throughout and following the procedure with no additional consequences.

• 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: 8523066
• Report Number: 2124215-2019-06891
• Device Sequence Number: 1928561
• Product Code: DQY
• UDI-Device Identifier: 08714729932628
• UDI-Public: 08714729932628
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132914
• 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
• Report Date (Section B): 04/17/2019

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: Lay User/Patient
• Device Expiration Date: 11/11/2020
• Device Model Number: 8105
• Device Catalogue Number: 8105
• Device Lot Number: 22927706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention