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 WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
  • 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 WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the package was contaminated.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.Before opening the sterilized package, the bottom of the package was open and the device dropped.The package might not be packed and sterilized correctly.The procedure was completed with another of the same device.No complications were reported and there was no patient injury.
 
Event Description
It was reported that the package was contaminated.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.Before opening the sterilized package, the bottom of the package was open and the device dropped.The package might not be packed and sterilized correctly.The procedure was completed with another of the same device.No complications were reported and there was no patient injury.
 
Manufacturer Narrative
E1 - initial reporter address: (b)(6).Device evaluated by mfr: the device was returned for analysis.An open carton was returned.Handwritten notes in black marker were found on the carton.The wolverine device was found to be coiled within its packaging hoop.This hoop containing the wolverine device was found to be inside a labelled tyvek pouch.There is no evidence of a bsci seal present on the tyvek pouch.No other issues were identified during the product analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WOLVERINE CORONARY CUTTING BALLOON MONORAIL
Type of Device
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11215907
MDR Text Key228243171
Report Number2134265-2021-00355
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/21/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0026221884
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Date Manufacturer Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-