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 - MAPLE GROVE 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 - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number H7493932430
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Vasoconstriction (2126)
Event Date 05/30/2016
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that distal tip detachment occurred.Vascular access was obtained via a radial approach.The patient's anatomy was noted to be tortuous.The physician was attempting to measure ffr in a lima graft when spasm occurred and the comet wire was stuck.Nitro was given.The physician pulled and turned the wire and the distal 4-5cm detached.The wire fragment was removed with a loop.The procedure was completed with another of the same comet wire.No further patient complications were reported and the patient's status is stable.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a ffr comet wire in two pieces.The shaft was separated approximately 17cm from the tip.The tip has some stretching of the coils.The shaft has some bends present approximately 26.5cm and 31cm from the tip.There is a slight kink at the seam weld 37cm from the tip.The sensor port was clear of material.Mtac testing revealed the device was found to be missing a small piece from the shaft.The separated piece was not returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that distal tip detachment occurred.Vascular access was obtained via a radial approach.The patient's anatomy was noted to be tortuous.The physician was attempting to measure ffr in a lima graft when spasm occurred and the comet wire was stuck.Nitro was given.The physician pulled and turned the wire and the distal 4-5cm detached.The wire fragment was removed with a loop.The procedure was completed with another of the same comet wire.No further patient complications were reported and the patient's status is stable.
 
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 - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5762708
MDR Text Key48616686
Report Number2134265-2016-05932
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/09/2016
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
Device Operator Health Professional
Device Expiration Date11/30/2016
Device Model NumberH7493932430
Device Lot Number0018976715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/09/2016
Initial Date FDA Received06/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight92
-
-