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

Model Number	MNC30023
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384); Sticking (1597); Device Issue (2379); Physical Resistance (2578); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician inflated balloon after adequately prepping and advanced the balloon to the lesion on an asahi blue scion wire.After inflating the balloon , physician attempted to remove the balloon but it was caught on the wire causing the physician to remove wire and balloon simultaneously.He attempted numerous times to remove the balloon prior to removing balloon and wire.

• 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: 7335031
• Report Number: 3009613036-2018-00006
• Device Sequence Number: 231450
• Product Code: LOX
• UDI-Device Identifier: 18906029358407
• UDI-Public: 18906029358407
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: MNC30023
• Device Catalogue Number: MNC30023
• Device Lot Number: MNCH01
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1