Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number 8900
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 02/25/2020
Event Type  malfunction  
Event Description
It was reported that a shaft break occurred.This comet pressure guidewire was selected for preparation; however, when removing the device from its box the shaft broke.The procedure was completed with another of the same device.
 
Event Description
It was reported that a shaft break occurred.This comet pressure guidewire was selected for preparation; however, when removing the device from its box the shaft broke.The procedure was completed with another of the same device.It was further reported that the break occurred at the proximal portion of the wire, close to the connection with the bluetooth hub.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COMET
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9811808
MDR Text Key182912336
Report Number2134265-2020-02418
Device Sequence Number1
Product Code DXO
UDI-Device Identifier08714729904397
UDI-Public08714729904397
Combination Product (y/n)N
PMA/PMN Number
K151610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/13/2020
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
Device Operator Health Professional
Device Expiration Date01/21/2022
Device Model Number8900
Device Catalogue Number8900
Device Lot Number0025088136
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/25/2020
Initial Date FDA Received03/10/2020
Supplement Dates Manufacturer Received03/18/2020
Supplement Dates FDA Received04/13/2020
Patient Sequence Number1
-
-