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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 MNC25028
Device Problems Difficult to Remove (1528); Device Issue (2379); Mechanical Jam (2983); Positioning Problem (3009)
Patient Problem No Information (3190)
Event Date 09/18/2017
Event Type  malfunction  
Manufacturer Narrative
The distal shaft of the catheter was found kinked. Thus, the inner lumen of the catheter did not allow guidewire advancement during lab analysis. A review of same lot history record identified no manufacturing nonconformities. Additionally, a review of the complaint history identified, no other incident from same lot. Based on the information reviewed, there is no indication of product quality issue with respect to manufacturing, design and labelling. Please note: this is the first electronic report being filed, and it was delayed due to the sign up process with the esg webtrader system.
 
Event Description
Mozectm nc rx percutaneous transluminal coronary angioplasty (ptca) 2. 50mm x 28mm was tracked over a non-cordis wire and inflated at twenty atmospheres (20atm). The balloon initially tacked well over the wire but after multiple inflations, when the user was pulling the balloon out, the wire got stuck into the balloon. The balloon and the wire were removed together and the balloon was rewired. The procedure was conducted for a chronic total occlusion (cto) of the left anterior descending (lad). No patient injury has been reported.
 
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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
muktanand marg, chala
vapi, gujarat 39619 1|
IN 396191|
Manufacturer Contact
narendra patel
bilakhia house, survey no. 135
muktanand marg, chala
muktanand marg, chala, vapi, in-gj 39619-1
IN   396191
MDR Report Key7033679
MDR Text Key93016768
Report Number3009613036-2017-00001
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 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2019
Device Model NumberMNC25028
Device Catalogue NumberMNC25028
Device Lot NumberMNCE49
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2016
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: 11/15/2017 Patient Sequence Number: 1
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