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
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528); Physical Property Issue (3008); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: 7443852
• Report Number: 3009613036-2018-00008
• Device Sequence Number: 19073146
• Product Code: LOX
• UDI-Device Identifier: 18906029358513
• UDI-Public: 18906029358513
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/19/2018

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: 10/09/2020
• Device Model Number: MNC40008
• Device Catalogue Number: MNC40008
• Device Lot Number: MNCI11
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1