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

Model Number	8103
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection noted that there were numerous kinks throughout the shaft.The shaft was cut all the way down and was jagged with the distal end/tip detached and not returned.The separated end was also jagged, which indicates there was trouble with cutting near the end of the device.There was delamination of the inner liner 4.5 cm to 9 cm from the separated end.Analysis determined that user error contributed to the clinical observations.
Event or Problem Description
It was reported that during an implant procedure the distal tip of this inner catheter broke off during the cutting process and initially remained loose in the outer catheter.The broken piece which measures approximately 2-3 cm was accidently pushed into the coronary sinus with another inner catheter where it remains.The physician reported that the coronary sinus was large and the catheter piece was in a stable position and did not appear likely to move away from that position.

• 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: 8079764
• Report Number: 2124215-2018-60188
• Device Sequence Number: 13518699
• Product Code: DQY
• UDI-Device Identifier: 08714729932543
• UDI-Public: 08714729932543
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: 8103
• Device Catalogue Number: 8103
• Device Lot Number: 21473748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 11/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 77 YR