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

Model Number MNC35015

Device Problems Defective Component (2292); Device Issue (2379); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

No issues were identified during the preparation and maneuvering the device to the target vessel.Review of device history records including raw material inspection, in process and finished product inspection does not reveal any discrepancy relevant to batch under investigation which conform that there is no indication of a product related quality deficiency associated to this batch.Control sample test results 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.

Event Description

No damage was noted to the device packaging.No issues noted when removing the device from the hoop.The device was prepared normally and the catheter performed as expected while in the patient.It was observed that the mozec balloon catheter sticking to interventional wire when removing from the patient.Two (2) of 3 balloons used during the procedure stuck to wire once outside of guide/touhy burst.It took extra effort to remove from wire (outside patient).The device was removed as single unit from the patient and no kink or bent were noted.The procedure was completed with another of the same device (mozec nc, lot # mncf27).No patient complications were reported and the patient's status was stable.Please note: this is the second report of two for the same event.Two balloons were used and this report is for the second balloon.

• 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: 7218959
• MDR Text Key: 98429359
• Report Number: 3009613036-2018-00002
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18906029358469
• UDI-Public: 18906029358469
• 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
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/27/2020
• Device Model Number: MNC35015
• Device Catalogue Number: MNC35015
• Device Lot Number: MNCF37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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
• Patient Age: 74 YR