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

Model Number MNC20008

Device Problems Device Operational Issue (2914); Difficult to Advance (2920); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

Review of device history record including (b)(4) material inspection, in process & finished product inspection does not reveal any discrepancy relevant to the batch under investigation which confirms that there is no indication of a product related quality deficiency associated to this batch.Additionally, a review of the complaint history identified no other incidents from this lot.

Event Description

A 2.0 x 8 mozec nc was advanced to a lesion in the rv marginal branch but it could not cross the lesion.Another ptca catheter (bsc - 2.0 x 8 nc emerge) used and the procedure completed.No issue to the patient noticed.

• 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: 7553235
• MDR Text Key: 109641988
• Report Number: 3009613036-2018-00015
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18906029358032
• UDI-Public: 18906029358032
• 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
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2020
• Device Model Number: MNC20008
• Device Catalogue Number: MNC20008
• Device Lot Number: MNCG33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• 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