• 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 H7493892815150
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Age at the time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter in two pieces. The balloon was tightly folded. The hypotube and inner/outer shaft was microscopically examined. The hypotube broke/fractured 82cm from the strain relief with kinks 46cm and 79cm from the strain relief. The fracture faces were oval as if kinked prior to separation. There was no evidence of any material or manufacturing deficiencies contributing to the damage. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. 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
Reportable based on device analysis completed on (b)(6) 2016. It was reported that shaft kink occurred. The target lesion was located in a coronary artery. A 1. 50mmx15mm maverick2(tm) balloon catheter was advanced to the lesion. However, during procedure, it was noted that the shaft was kinked. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed hypotube break.
 
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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5976404
MDR Text Key55576049
Report Number2134265-2016-08299
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberH7493892815150
Device Catalogue Number38928-1515
Device Lot Number19191679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-