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

Model Number	MNC30015
Medical Device Problem Codes	Difficult to Remove (1528); Device Operational Issue (2914); Human Factors Issue (2948); Human-Device Interface Problem (2949); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician used a 3.0x15 mozec nc to pre-dilate during a coronary intervention procedure.Everything was fine getting the balloon to the lesion since it was still not inflated.When they went to inflate mozec nc balloon, it would not move and was observed to be fused to the wire.The physician reported having some difficulty getting the wire and balloon out, but eventually was able to remove the wire and the mozec nc balloon that was stuck on it.Unfortunately they did not save the mozec nc balloon and threw out the wire with the mozec nc balloon stuck on it.

• 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: 7330372
• Report Number: 3009613036-2018-00003
• Device Sequence Number: 18869857
• Product Code: LOX
• UDI-Device Identifier: 18906029358384
• UDI-Public: 18906029358384
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2018

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 Model Number: MNC30015
• Device Catalogue Number: MNC30015
• 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: 02/10/2018
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1