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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CROSSBOSS CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION CROSSBOSS CATHETER, PERCUTANEOUS Back to Search Results
Model Number 10592
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis. Returned product consisted of a crossboss micro-catheter, but there was no indication if the fm (foreign material) was returned for analysis. When analyzed, there was no fm in the bio-hazard bag with the device. The hub, shaft, torque device, and tip were visually and microscopically inspected. Inspection of the device presented no damage or irregularities to the device. The guidewire used in the procedure was not returned for analysis, so a test guidewire was used for functional testing. The test wire was advanced through the shaft of the device with no resistance or issues. When the guidewire was advanced back and forth, a bloody fluid came out of the tip but no fm came out of the shaft.
 
Event Description
It was reported that a foreign material was present in the device. The target lesion was located in the totally occluded right coronary artery. A crossboss re-entry device was selected for use. During the procedure inside the patient, several wires were tried to advanced through the crossboss but was unable to advance to the crossboss. The crossboss was then taken out and when flushing was performed, a blue material that was particle of a blue sterile towel flushed out. The procedure was completed with a different device. No patient complications were reported and the patient was fine.
 
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Brand NameCROSSBOSS
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
500 commander shea boulevard
quincy MA 02171
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9289884
MDR Text Key168469435
Report Number2134265-2019-13405
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/12/2020
Device Model Number10592
Device Catalogue Number10592
Device Lot Number0023239035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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