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

Model Number	MNC20008
Medical Device Problem Codes	Device Operational Issue (2914); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of device history record including (b)(4) 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.Additionally, a review of the complaint history identified no other incidents from this lot.
Event or Problem Description
A 2.0 x 8 mozec nc was advanced to a lesion in the rv marginal branch but it could not cross the lesion.Another ptca catheter (bsc - 2.0 x 8 nc emerge) used and the procedure completed.No issue to the patient noticed.

• Brand Name: MOZEC ¿ NC - 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: 7553235
• Report Number: 3009613036-2018-00015
• Device Sequence Number: 178319
• Product Code: LOX
• UDI-Device Identifier: 18906029358032
• UDI-Public: 18906029358032
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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: 06/07/2020
• Device Model Number: MNC20008
• Device Catalogue Number: MNC20008
• Device Lot Number: MNCG33
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1