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U.S. Department of Health and Human Services

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

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MERIL LIFE SCIENCES PVT. LTD. MOZECTM RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER Back to Search Results
Model Number MOZ20012
Device Problems Sticking (1597); Physical Resistance (2578); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2018
Event Type  malfunction  
Manufacturer Narrative
The concomitant device mozectm - rx ptca balloon dilatation catheter was returned for analysis. The product was received with the guidewire stuck to the balloon catheter. A visual examination of balloon identified that the balloon had blood and saline traces in it and the balloon was stuck on the guidewire. A visual and tactile examination of the hypotube revealed multiple kinks on proximal shaft and at the rx port, and bend near the luer hub. Further, the catheter shaft was observed to be deformed. 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. Balloon preparation, deployment and retraction test (simulated use) were performed on one (01) control sample from the same lot (lot # umoc34) of mozectm - rx ptca balloon dilatation catheter. No evidence of blocking of the catheter guidewire lumen during the flushing of the catheter guidewire lumen was noticed. The mozectm was prepared to access the simulated coronary vasculature and inflated to rated burst pressure without encountering any resistance or causing kink, bend, breakage or any other visual damage. Also the catheter was removed from the deployment site without any resistance or causing kink, bend, breakage or any other visual damage to the catheter or accessory devices. Review of device history records including raw material inspection, in process & 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 confirms 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
Physician was attempting to pre dilatate the left circumflex artery. The mozec 2. 00x12 was loaded on a shinobi. 014 wire and inserted into the lesion. After predilation, the mozec was hung on the wire and the wire / balloon were removed as a unit. The balloon is still loaded on that wire. To complete the procedure the physician rewired the vessel and inserted an abbott balloon.
 
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Brand NameMOZECTM 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 Key7477760
MDR Text Key107698976
Report Number3009613036-2018-00011
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131169
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 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/26/2020
Device Model NumberMOZ20012
Device Catalogue NumberMOZ20012
Device Lot NumberUMOC34
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2017
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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