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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 MNC40008
Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Physical Property Issue (3008); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2018
Event Type  malfunction  
Manufacturer Narrative
A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. Control sample test result of the same manufacturing lot again conforms that there was no indication of a product quality deficiency. Additionally, a review of the complaint history identified no other incidents from this lot. During processing of this complaint, attempts were made to obtain the concomitant device and applicable information relevant to the report. If additional information or the concomitant device received in the future, a supplemental report will be issued.
 
Event Description
The balloon was taken above rated burst pressure (rbp) and was difficult to remove from the body. It was sticking to the wire but was eventually removed.
 
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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 Key7443852
MDR Text Key106627425
Report Number3009613036-2018-00008
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 04/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/09/2020
Device Model NumberMNC40008
Device Catalogue NumberMNC40008
Device Lot NumberMNCI11
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 Received03/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2017
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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