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

Model Number	MOZ22533
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384); Difficult to Remove (1528); Sticking (1597); Device Issue (2379); Physical Resistance (2578)
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 used a semi compliant mozec balloon to pre-dilate in the rca.After deflating the balloon, while pulling back the balloon catheter, physician noticed it was somewhat difficult to pull out, however the wire was moving.Physician looked under fluoro and observed that the wire was not past the balloon catheter, thus, wire came out before the balloon because semi compliant mozec balloon was stuck on the wire.Had to pull wire out with mozec balloon stuck on it.Had to use another wire to complete procedure.

• 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: 7335092
• Report Number: 3009613036-2018-00004
• Device Sequence Number: 16169928
• Product Code: LOX
• UDI-Device Identifier: 18904224907666
• UDI-Public: 18904224907666
• 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): 03/13/2018

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: MOZ22533
• Device Catalogue Number: MOZ22533
• 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: 02/13/2018
• 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