• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIL LIFE SCIENCES PVT. LTD. MOZEC NC- RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER

  • 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
 

MERIL LIFE SCIENCES PVT. LTD. MOZEC NC- RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER Back to Search Results
Model Number MNC30015
Device Problems Difficult to Remove (1528); Device Operational Issue (2914); Human Factors Issue (2948); Human-Device Interface Problem (2949); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2018
Event Type  malfunction  
Event Description
Physician used a 3. 0x15 mozec nc to pre-dilate during a coronary intervention procedure. Everything was fine getting the balloon to the lesion since it was still not inflated. When they went to inflate mozec nc balloon, it would not move and was observed to be fused to the wire. The physician reported having some difficulty getting the wire and balloon out, but eventually was able to remove the wire and the mozec nc balloon that was stuck on it. Unfortunately they did not save the mozec nc balloon and threw out the wire with the mozec nc balloon stuck on it.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMOZEC NC- RX PTCA BALLOON DILATATION CATHETER
Type of DeviceRAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
Manufacturer (Section D)
MERIL LIFE SCIENCES PVT. LTD.
bilakhia house, survey no. 135
muktanand marg
chala, vapi 39619 1
IN 396191
Manufacturer (Section G)
MERIL LIFE SCIENCES PVT. LTD.
bilakhia house, survey no. 135
muktanand marg
chala, vapi 39619 1
IN 396191
Manufacturer Contact
narendra patel
bilakhia house, survey no. 135
muktanand marg
chala, vapi 39619-1
IN   396191
MDR Report Key7330372
MDR Text Key102327795
Report Number3009613036-2018-00003
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMNC30015
Device Catalogue NumberMNC30015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-