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

Model Number	MOZ15012
Medical Device Problem Codes	Difficult to Remove (1528); Sticking (1597); Device Issue (2379); Failure to Advance (2524); 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	02/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported using a semi compliant mozec balloon during a coronary cto case.Balloon was difficult to deliver but was able to pre-dilate lesion.After deflating semi compliant mozec balloon, while working back the balloon catheter, it was tight on the wire.Was able to get back to guide and tuohey, but couldn't get much past monorail.Concluded semi complaint mozec balloon was stuck on the wire.In order to remove, had to pinch wire to remove mozec balloon from the wire.Thus, mozec balloon was stuck on the wire.

• Brand Name: MOZECTM 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: 7335057
• Report Number: 3009613036-2018-00005
• Device Sequence Number: 10917644
• Product Code: LOX
• UDI-Device Identifier: 18904224907550
• UDI-Public: 18904224907550
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• 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 Model Number: MOZ15012
• Device Catalogue Number: MOZ15012
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• 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