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

Model Number MOZ22533

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Difficult to Remove (1528); Sticking (1597); Device Issue (2379); Physical Resistance (2578)

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

Event Date 02/09/2018

Event Type  malfunction  

Event 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
• 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: 7335092
• MDR Text Key: 102353274
• Report Number: 3009613036-2018-00004
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18904224907666
• UDI-Public: 18904224907666
• 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: 03/13/2018

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: Health Professional
• Device Model Number: MOZ22533
• Device Catalogue Number: MOZ22533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• 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