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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

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MERIL LIFE SCIENCES PVT. LTD. MOZEC NC- RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER Back to Search Results
Model Number MNC30023
Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Sticking (1597); Device Issue (2379); Physical Resistance (2578); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2018
Event Type  malfunction  
Event Description
Physician inflated balloon after adequately prepping and advanced the balloon to the lesion on an asahi blue scion wire. After inflating the balloon , physician attempted to remove the balloon but it was caught on the wire causing the physician to remove wire and balloon simultaneously. He attempted numerous times to remove the balloon prior to removing balloon and wire.
 
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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 Key7335031
MDR Text Key102588895
Report Number3009613036-2018-00006
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
Remedial Action Replace
Type of Report Initial
Report Date 03/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberMNC30023
Device Catalogue NumberMNC30023
Device Lot NumberMNCH01
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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