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
Medical Device Problem Codes	Sticking (1597); Device Issue (2379); Physical Resistance (2578); Physical Property Issue (3008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 7491074
• Report Number: 3009613036-2018-00013
• Device Sequence Number: 239064
• Product Code: LOX
• UDI-Device Identifier: 18906029358223
• UDI-Public: 18906029358223
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR