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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIL LIFE SCIENCES PVT. LTD. MOZECTM NC- RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER

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MERIL LIFE SCIENCES PVT. LTD. MOZECTM NC- RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER Back to Search Results
Model Number MNC25015
Device Problems Sticking (1597); Device Issue (2379); Physical Resistance (2578); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2018
Event Type  malfunction  
Manufacturer Narrative
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 confirms 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 confirmed 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
The mozec 2. 5 x 15 mm nc was used to post dilate while on asahi 0. 014" fielder xt-a wire. The balloon was inflated to 20 rbp and it appeared to be working well. After deflating mozec balloon, fellow dr. (b)(6) noticed it was slightly difficult to move back. Was able to get balloon and wire back into guide catheter. Then, had to clamp the wire to get mozec nc balloon off of the asahi fielder xt-a wire.
 
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Brand NameMOZECTM 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 Key7491074
MDR Text Key108140808
Report Number3009613036-2018-00013
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 05/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/26/2020
Device Model NumberMNC25015
Device Catalogue NumberMNC25015
Device Lot NumberMNCF33
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 Received04/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2017
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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