• 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 NC QUANTUM APEX¿ 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 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493912420200
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter. The hypotube and shaft were examined. The reported separation was not confirmed. Inspection of the remainder of the device, revealed no other damage or irregularities. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. Bsc id (b)(4) / tw (b)(4).
 
Event Description
It was reported that a shaft break occurred. During unpacking of a 20mm x 2. 00mm nc quantum apex¿ balloon catheter, it was noted that the shaft was broken in the middle. The device was not used inside the patient. The procedure was completed with another of the same device.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a shaft break occurred. During unpacking of a 20 mm x 2. 00 mm nc quantum apex¿ balloon catheter, it was noted that the shaft was broken in the middle. The device was not used inside the patient. The procedure was completed with another of the same device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC QUANTUM APEX¿
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 Key6654067
MDR Text Key212972839
Report Number2134265-2017-06036
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberH7493912420200
Device Catalogue Number39124-2020
Device Lot Number20304352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-