• 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 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

  • 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 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493892820250
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 shaft break occurred. A 2. 50mm x 20mm maverick²¿ balloon catheter was selected for dilation. However, it was noted during preparation that the device broke into two pieces. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of a maverick 2 balloon catheter in two pieces. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 66. 3cm from the hub. The fracture faces were oval as if kinked prior to separation. There are numerous hypotube and shaft kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact. (b)(4).
 
Event Description
It was reported that shaft break occurred. A 2. 50mm x 20mm maverick balloon catheter was selected for dilation. However, it was noted during preparation that the device broke into two pieces. No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAVERICK²¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7284136
MDR Text Key100664532
Report Number2134265-2018-00955
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729370185
UDI-Public08714729370185
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/05/2020
Device Model NumberH7493892820250
Device Catalogue Number38928-2025
Device Lot Number21221968
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-