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

Model Number	MNC35013
Medical Device Problem Codes	Sticking (1597); Device Issue (2379); Failure to Advance (2524); Physical Resistance (2578); Difficult to Advance (2920); Physical Property Issue (3008); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported having used a 3.5x13mm mozec nc to post dilate during coronary intervention.After deflating balloon, physician noticed it was stuck on sion blue wire.Had to remove wire with the 3.5x13 nc mozec balloon stuck on it.Event occured during the procedure inside the patient.No patient injury has been reported.

• 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: 7347455
• Report Number: 3009613036-2018-00007
• Device Sequence Number: 11094223
• Product Code: LOX
• UDI-Device Identifier: 18906029358452
• UDI-Public: 18906029358452
• 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): 03/16/2018

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: 06/09/2020
• Device Model Number: MNC35013
• Device Catalogue Number: MNC35013
• Device Lot Number: MNCG58
• 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: 02/17/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR