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U.S. Department of Health and Human Services

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

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MERIL LIFE SCIENCES PVT. LTD. MOZEC¿ RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER Back to Search Results
Model Number MOZ30020
Device Problems Defective Component (2292); Device Issue (2379); Physical Property Issue (3008)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Event Date 12/06/2017
Event Type  malfunction  
Event Description
The balloon would not inflate inside or outside the body. There were neither patient complications nor injuries reported. No additional information was provided.
 
Manufacturer Narrative
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 inflation and deflation time test is performed in one control sample from the same lot of mozec¿ rx ptca balloon dilatation catheter under investigation (lot# umob06) to determine the time required to inflate the mozec¿ to claim rated burst pressure (16 atm) and then the balloon deflation time. Control sample test results are also conformed to the test acceptance criteria. 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. Furthermore, controls sample test results of the same manufacturing lot again conform that there was no indication of a product quality deficiency relevant to inflation and deflation. Additionally, a review of the complaint history identified no other similar incidents from this lot. The concomitant device, mozectm - rx ptca balloon dilatation catheter was returned for analysis. The balloon, bonds, and tip were microscopically and visually examined. A visual examination of the returned device observed no tip damage and stylet movement was hard. The length of the tip was measured 3. 5 mm, which met its specification. Microscopic examination presented no irregularities in the balloon material and the bonds could have contributed to the damage. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. There was solidified contras media the inflation lumen and balloon. A visual and tactile examination of distal and proximal shaft revealed kink near rx port and multiple kinks on the hypotube. Device was dissected for further investigation and observed solidified contrast media at the joint between outer shaft to hypotube, this clogged the inflation lumen. Contrast media is not used in manufacturing. There was no evidence of any material or manufacturing deficiencies contributing to the reported difficulty. Additionally, a review of the complaint history identified no other similar incidents reported from this lot. The investigation conclusion is operational in context as the product meets the design and manufacture specification but due to procedural factors encountered during the procedure.
 
Manufacturer Narrative
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 inflation and deflation time test is performed in one control sample from the same lot of mozec¿ rx ptca balloon dilatation catheter under investigation (lot# umob06) to determine the time required to inflate the mozec¿ to claim rated burst pressure (16 atm) and then the balloon deflation time. Control sample test results are also conformed to the test acceptance criteria. 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. Furthermore, controls sample test results of the same manufacturing lot again conform that there was no indication of a product quality deficiency relevant to inflation and deflation. Additionally, a review of the complaint history identified no other similar incidents from this lot.
 
Event Description
The balloon would not inflate inside or outside the body. There were neither patient complications nor injuries reported. No additional information was provided.
 
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Brand NameMOZEC¿ 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
MDR Report Key7166862
MDR Text Key282034181
Report Number3009613036-2018-00001
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K131169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2020
Device Model NumberMOZ30020
Device Catalogue NumberMOZ30020
Device Lot NumberUMOB06
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2017
Is This a Reprocessed and Reused Single-Use Device? No

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