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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 MOZ25009
Device Problems Mechanical Problem (1384); Failure to Advance (2524); Patient-Device Incompatibility (2682); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2017
Event Type  malfunction  
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information. There was no leak noted during preparation prior to use, which suggests a product quality issue did not contribute to the reported difficulties. Patient anatomy especially lesion morphology such as highly calcified & narrow lesion, vessel tortuosity, thrombus burden can likely contribute to the crossing/withdrawal difficulties. Patient had very tortuous vessels. Aforesaid tortuous vessel might have offered high resistance while maneuvering the catheter system which led to the reported problem. Returned product analysis reveals a kink on the proximal shaft near the luer hub. Such type of kink is associated with excessive force being applied on balloon catheter during use. 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. It might be possible that highly tortuous vessel offered high resistance during lesion crossing that led to the reported case. However, as clinical situation cannot be duplicated in our analysis lab, the exact root cause of the difficulty could not be determined.
 
Event Description
Balloon was unable to cross. Patient had very tortuous vessels. Dr. Park started radially and had to switch to groin due to tortuous vessels. He tried to cross with a mozec 2. 5x09 balloon. He ended up using a competitor over the wire balloon of same size just to get extra pushability to get across lesion (he never inflated that balloon), then he used a larger sizen mozec3. 0x09 balloon and was able to get across lesion and pre-dilate prior to stenting. There was no reported clinically significant delay in the procedure. There was no reported patient injury.
 
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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
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 Key7064464
MDR Text Key93769672
Report Number3009613036-2017-00004
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 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2020
Device Model NumberMOZ25009
Device Catalogue NumberMOZ25009
Device Lot NumberUMOA87
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/28/2017 Patient Sequence Number: 1
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