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U.S. Department of Health and Human Services

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

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MERIL LIFE SCIENCES PVT. LTD. MOZECTM RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER Back to Search Results
Model Number MOZ15012
Device Problems Difficult to Remove (1528); Sticking (1597); Device Issue (2379); Failure to Advance (2524); Physical Resistance (2578); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2018
Event Type  malfunction  
Event Description
Physician reported using a semi compliant mozec balloon during a coronary cto case. Balloon was difficult to deliver but was able to pre-dilate lesion. After deflating semi compliant mozec balloon, while working back the balloon catheter, it was tight on the wire. Was able to get back to guide and tuohey, but couldn't get much past monorail. Concluded semi complaint mozec balloon was stuck on the wire. In order to remove, had to pinch wire to remove mozec balloon from the wire. Thus, mozec balloon was stuck on the wire.
 
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Brand NameMOZECTM 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 Key7335057
MDR Text Key102353318
Report Number3009613036-2018-00005
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131169
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 Model NumberMOZ15012
Device Catalogue NumberMOZ15012
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 Received02/12/2018
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

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