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 INTELLATIP MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
  • 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 INTELLATIP MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 87162
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Event Description
It was reported that a foreign object was found inside the sterilization bag after unpacking the box containing the intellatip mifi catheter.When the bag was checked closely, there were plastic pieces found.Since the coating of the main unit handle peeled off, it is possible that it was part of the plastic pieces.No patient complications were reported.A different catheter was used to complete the procedure.
 
Event Description
It was reported that a foreign object was found inside the sterilization bag after unpacking the box containing the intellatip mifi catheter.When the bag was checked closely, there were plastic pieces found.Since the coating of the main unit handle peeled off, it is possible that it was part of the plastic pieces.No patient complications were reported.A different catheter was used to complete the procedure.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed that particles of a foreign material were encountered inside the sealed pouch and around the steering knob, and the residues found looked similar between them.The particles found matched with the foreign material observed in the pictures provided by the customer.During the manufacturing process, the device was not correctly assembled, due to foreign materials found in the edges of the sealed pouch and around the steering knob.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTELLATIP MIFI XP
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12032055
MDR Text Key257151279
Report Number2134265-2021-07891
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729848042
UDI-Public08714729848042
Combination Product (y/n)N
PMA/PMN Number
P020025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/07/2023
Device Model Number87162
Device Catalogue Number87162
Device Lot Number0026475833
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Date Manufacturer Received07/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-