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

Model Number	MOZ30020
Medical Device Problem Codes	Defective Component (2292); Device Issue (2379); Physical Property Issue (3008)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The balloon would not inflate inside or outside the body.There were neither patient complications nor injuries reported.No additional information was provided.
Event or Problem Description
The balloon would not inflate inside or outside the body.There were neither patient complications nor injuries reported.No additional information was provided.
Additional 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.

• Brand Name: MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
• Common Device Name: RAPID 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 Key: 7166862
• Report Number: 3009613036-2018-00001
• Device Sequence Number: 16478876
• Product Code: LOX
• UDI-Device Identifier: 18904224907901
• UDI-Public: 18904224907901
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K131169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: MOZ30020
• Device Catalogue Number: MOZ30020
• Device Lot Number: UMOB06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1