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

Model Number MNC30023

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Sticking (1597); Device Issue (2379); Physical Resistance (2578); Difficult to Advance (2920); Positioning Problem (3009)

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

Event Date 02/12/2018

Event Type  malfunction  

Event Description

Physician inflated balloon after adequately prepping and advanced the balloon to the lesion on an asahi blue scion wire.After inflating the balloon , physician attempted to remove the balloon but it was caught on the wire causing the physician to remove wire and balloon simultaneously.He attempted numerous times to remove the balloon prior to removing balloon and wire.

• Brand Name: MOZEC NC- 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: 7335031
• MDR Text Key: 102588895
• Report Number: 3009613036-2018-00006
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18906029358407
• UDI-Public: 18906029358407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160961
• 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 Expiration Date: 06/30/2020
• Device Model Number: MNC30023
• Device Catalogue Number: MNC30023
• Device Lot Number: MNCH01
• 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
• Date Device Manufactured: 07/01/2017
• 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