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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIL LIFE SCIENCES PRIVATE LIMITED MOZEC¿ NC - RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER

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MERIL LIFE SCIENCES PRIVATE LIMITED MOZEC¿ NC - RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER Back to Search Results
Model Number MNC30015
Device Problem Retraction Problem (1536)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Review of batch manufacturing records including raw 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. Control sample test results confirm that there was no indication of a product quality deficiency in the batch under investigation. Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made. Based on the available information and without the concomitant device, it is not possible to draw a clinical conclusion between the device and the reported event. Review of the complaint history identified no other incidents reported from this lot. Considering all above and as the clinical situations cannot be duplicated in our analysis lab, a conclusive cause for the reported incident, and the relationship to the product, if any, cannot be determined. Neither the dhr review nor the control sample analysis including complaint history review suggests that the reported failures could be related to the design or the manufacturing process. Note: this complaint is received from outside the usa. No units from this batch has been distributed in the usa. However, it is being reported to the fda as this product is cleared in the usa. (b)(4).
 
Event Description
As reported, 3. 00 x 15mm mozec(tm) nc rx ptca balloon dilatation catheter, batch #: mnco52 was used in a pci. While withdrawing, it was very difficult to retrieve without taking the guide wire. This increase the radiation time.
 
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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 PRIVATE LIMITED
survey number 135/139
bilakhia house, muktanand marg
chala, vapi, gujarat 39619 1
IN 396191
Manufacturer (Section G)
MERIL LIFE SCIENCES PRIVATE LIMITED
survey number 135/139
bilakhia house, muktanand marg
chala, vapi, gujarat 39619 1
IN 396191
Manufacturer Contact
narendra patel
survey number 135/139
bilakhia house, muktanand marg
chala, vapi, gujarat 39619-1
IN   396191
MDR Report Key9834371
MDR Text Key203124731
Report Number3009613036-2020-00002
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCE
PMA/PMN Number
K160961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model NumberMNC30015
Device Catalogue NumberMNC30015
Device Lot NumberMNCO52
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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