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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 MOZ25014
Device Problems Patient-Device Incompatibility (2682); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2017
Event Type  malfunction  
Manufacturer Narrative
Unable to get balloon to cross over lesion.
 
Event Description
Physician was unable to advance the device through or past the target lesion. He said it was a little bulky and the patient had very tortuous vessels. He was able to get a competitor balloon of the same size to cross lesion and work well. No injury to patient and the patient is reported to be doing well.
 
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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
muktanand marg, chala
vapi, gujarat 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 Key7045108
MDR Text Key93199511
Report Number3009613036-2017-00002
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,health profession
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/20/2020
Device Model NumberMOZ25014
Device Catalogue NumberMOZ25014
Device Lot NumberUMOA84
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 Received10/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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

Patient Treatment Data
Date Received: 11/20/2017 Patient Sequence Number: 1
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