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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 MNC35015
Device Problems Defective Component (2292); Device Issue (2379); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2018
Event Type  malfunction  
Manufacturer Narrative
No issues were identified during the preparation and maneuvering the device to the target vessel. Review of device history records including raw material inspection, in process and finished product inspection does not reveal any discrepancy relevant to batch under investigation which conform that there is no indication of a product related quality deficiency associated to this batch. Control sample test results 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.
 
Event Description
No damage was noted to the device packaging. No issues noted when removing the device from the hoop. The device was prepared normally and the catheter performed as expected while in the patient. It was observed that the mozec balloon catheter sticking to interventional wire when removing from the patient. Two (2) of 3 balloons used during the procedure stuck to wire once outside of guide/touhy burst. It took extra effort to remove from wire (outside patient). The device was removed as single unit from the patient and no kink or bent were noted. The procedure was completed with another of the same device (mozec nc, lot # mncf27). No patient complications were reported and the patient's status was stable. Please note: this is the second report of two for the same event. Two balloons were used and this report is for the second balloon.
 
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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 Key7218959
MDR Text Key98429359
Report Number3009613036-2018-00002
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 01/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/27/2020
Device Model NumberMNC35015
Device Catalogue NumberMNC35015
Device Lot NumberMNCF37
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 Received01/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2017
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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