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

Model Number MNC25015

Device Problems Sticking (1597); Device Issue (2379); Physical Resistance (2578); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

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 confirms 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 confirmed 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

The mozec 2.5 x 15 mm nc was used to post dilate while on asahi 0.014" fielder xt-a wire.The balloon was inflated to 20 rbp and it appeared to be working well.After deflating mozec balloon, fellow dr.(b)(6) noticed it was slightly difficult to move back.Was able to get balloon and wire back into guide catheter.Then, had to clamp the wire to get mozec nc balloon off of the asahi fielder xt-a wire.

• Brand Name: MOZECTM 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: 7491074
• MDR Text Key: 108140808
• Report Number: 3009613036-2018-00013
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18906029358223
• UDI-Public: 18906029358223
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2020
• Device Model Number: MNC25015
• Device Catalogue Number: MNC25015
• Device Lot Number: MNCF33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• 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: 60 YR