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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 MNC20008
Device Problems Device Operational Issue (2914); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/30/2018
Event Type  malfunction  
Manufacturer Narrative
Review of device history record including (b)(4) material inspection, in process & finished product inspection does not reveal any discrepancy relevant to the batch under investigation which confirms that there is no indication of a product related quality deficiency associated to this batch. Additionally, a review of the complaint history identified no other incidents from this lot.
 
Event Description
A 2. 0 x 8 mozec nc was advanced to a lesion in the rv marginal branch but it could not cross the lesion. Another ptca catheter (bsc - 2. 0 x 8 nc emerge) used and the procedure completed. No issue to the patient noticed.
 
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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 Key7553235
MDR Text Key109641988
Report Number3009613036-2018-00015
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 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/07/2020
Device Model NumberMNC20008
Device Catalogue NumberMNC20008
Device Lot NumberMNCG33
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 Received05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2017
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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