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

Model Number MNC40008

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Physical Property Issue (3008); Positioning Problem (3009)

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

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Control sample test result of the same manufacturing lot again conforms that there was no indication of a product quality deficiency.Additionally, a review of the complaint history identified no other incidents from this lot.During processing of this complaint, attempts were made to obtain the concomitant device and applicable information relevant to the report.If additional information or the concomitant device received in the future, a supplemental report will be issued.

Event Description

The balloon was taken above rated burst pressure (rbp) and was difficult to remove from the body.It was sticking to the wire but was eventually removed.

• 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: 7443852
• MDR Text Key: 106627425
• Report Number: 3009613036-2018-00008
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18906029358513
• UDI-Public: 18906029358513
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: MNC40008
• Device Catalogue Number: MNC40008
• Device Lot Number: MNCI11
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2017
• 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