• 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 QUANTUM¿ MAVERICK¿ 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 QUANTUM¿ MAVERICK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493808015300
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. :returned product consisted of a quantum maverick balloon catheter. The tip, balloon, markerbands, bonds, and inner shaft were microscopically and visually examined. There was contrast in the inflation lumen and balloon. The balloon was loosely folded. Microscopic examination of the device revealed that 1. 2cm of the outer shaft was inflated at the proximal balloon bond. Functional testing was performed by attaching an inflation device filled with water to the device. When positive pressure was applied, the shaft burst at 6 atm. The shaft was microscopically examined and there were no irregularities in the shaft material or bonds that could have contributed to the inflation. Inspection of the remainder of the device revealed no other damage or irregularities. No other issues were identified during the product analysis. There is no indication the device was inflated over rated burst pressure (rbp). 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
It was further reported that after the first dilatation was performed without problem, the device was advanced and inflated for the second time when the irregular expansion was observed under x-ray.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that inflation of the shaft occurred. The 80% stenosed, 28x3mm target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery. A 3. 0mm x 15mm quantum¿ maverick¿ balloon catheter was advanced for dilatation. However, during the first inflation at 12 atmospheres, it was noted that a portion of the shaft would also inflate together with the balloon. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUANTUM¿ MAVERICK¿
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 Key6605804
MDR Text Key163072560
Report Number2134265-2017-05630
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,Followup
Report Date 05/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberH7493808015300
Device Catalogue Number38080-1530
Device Lot Number19970104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-