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 DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  • 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 DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number 86706
Device Problem Difficult to Remove (1528)
Patient Problem Atrial Fibrillation (1729)
Event Date 01/14/2021
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported that at the end of a procedure to treat atrial fibrillation with a dynamic xt electrode catheter, the patient was in atrial fibrillation.The physician proceeded to perform an internal shock (41j) then an external (200j).He then tried to remove the catheter present in the distal portion of the coronary sinus, which was stuck / stuck to the wall (heating due to internal electric shock).The physician used an non-boston scientific sheath in order to remove the catheter from the coronary sinus (he cut the handle of the catheter) and succeeded in removing the catheter from the patient.Extraction was performed by gentle and progressive pressure.There was no pericardial effusion at extraction and at 10 minutes.The patient was well and did not encounter any other problems.The device is expected to be returned for analysis.
 
Event Description
It was reported that at the end of a procedure to treat atrial fibrillation with a dynamic xt electrode catheter, the patient was in atrial fibrillation.The physician proceeded to perform an internal shock (41j) then an external (200j).He then tried to remove the catheter present in the distal portion of the coronary sinus, which was stuck / stuck to the wall (heating due to internal electric shock).The physician used an non-boston scientific sheath in order to remove the catheter from the coronary sinus (he cut the handle of the catheter) and succeeded in removing the catheter from the patient.Extraction was performed by gentle and progressive pressure.There was no pericardial effusion at extraction and at 10 minutes.The patient was well and did not encounter any other problems.The device has been returned for analysis.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed the returned device was completely damaged.The catheter was cut approximately at 95 cm from the distal end.The proximal end of the catheter had a suture tied around it.The catheter surface showed drag marks, indicating it was in contact with a sharp edge or a rough surface.The coil showed different kinks in its exposed section.The distal tip did not show damages, it was in good condition.No more visual damages were found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DYNAMIC XT
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11230591
MDR Text Key228691025
Report Number2134265-2021-00789
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729877615
UDI-Public08714729877615
Combination Product (y/n)N
PMA/PMN Number
K921872
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/17/2021
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 Date09/03/2023
Device Model Number86706
Device Catalogue Number86706
Device Lot Number0025964120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2021
Initial Date Manufacturer Received 01/14/2021
Initial Date FDA Received01/26/2021
Supplement Dates Manufacturer Received03/09/2021
Supplement Dates FDA Received03/17/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
Patient Weight80
-
-