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 Problems Contamination (1120); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a comet dropped on the floor.During preparation and while outside the patient, a comet pressure guidewire was being removed from the packaging, but dropped on the floor.It was noted that the internal plastic sheet on the opposite side of the planned opening strap of the comet packaging was removed, but the interlayer suddenly tore off into two parts and the comet pressure guidewire dropped on the floor.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.
 
Event Description
It was reported that a comet dropped on the floor.During preparation and while outside the patient, a comet pressure guidewire was being removed from the packaging, but dropped on the floor.It was noted that the internal plastic sheet on the opposite side of the planned opening strap of the comet packaging was removed, but the interlayer suddenly tore off into two parts and the comet pressure guidewire dropped on the floor.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Evaluation by mfr: the original packaging was returned to boston scientific for analysis.No device was returned.The returned packaging was examined for damage or any irregularities.The packaging showed it was opened incorrectly.The packaging was not opened at the recommended area, it was opened upside down on the opposite end of the sterile barrier opening.Inspection of the remainder of the packaging, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for packaging issues.
 
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 Key10596647
MDR Text Key208856509
Report Number2134265-2020-13291
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 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/16/2022
Device Model Number8900
Device Catalogue Number8900
Device Lot Number0025362296
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Date Manufacturer Received10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-