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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY PRO; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION ACUITY PRO; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 8101
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/31/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that this catheter tore apart during a procedure two centimeter distal to hub and tore perpendicular to catheter length and cross cut.The physician had not started with the cutter yet during this incident.The catheter was never in service.No adverse patient effects were reported.
 
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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 Key10775694
Report Number2124215-2020-22393
Device Sequence Number14406444
Product Code DQY
UDI-Device Identifier08714729932468
UDI-Public08714729932468
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K132914
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/02/2020
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 Date01/01/2022
Device Model Number8101
Device Catalogue Number8101
Device Lot Number24978886
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/31/2020
Initial Report FDA Received Date11/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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