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

Model Number MOZ15012

Device Problems Difficult to Remove (1528); Sticking (1597); Device Issue (2379); Failure to Advance (2524); Physical Resistance (2578); Difficult to Advance (2920); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  malfunction  

Event 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
• Type of Device: 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
• Manufacturer (Section G): MERIL LIFE SCIENCES PVT. LTD.; bilakhia house, survey no. 135; muktanand marg; chala, vapi 39619 1; IN 396191
• Manufacturer Contact: narendra patel ; bilakhia house, survey no. 135; muktanand marg; chala, vapi 39619-1 ; IN 396191
• MDR Report Key: 7335057
• MDR Text Key: 102353318
• Report Number: 3009613036-2018-00005
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18904224907550
• UDI-Public: 18904224907550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MOZ15012
• Device Catalogue Number: MOZ15012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1