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

Model Number	MOZ25009
Medical Device Problem Codes	Device Issue (2379); Patient-Device Incompatibility (2682); Device Operational Issue (2914); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to cross lesion.A 80% stenosis observed.Target lesion was lad.Please note: mdr is being submitted late due to technical issues with esg and the webtrader production account.
Event or Problem Description
Balloon was unable to cross lesion.They used a competitor balloon of a little smaller diameter and it was able to cross lesion.No injury to patient and the patient is reported to be doing well.

• Brand Name: MOZECTM RX PTCA BALLOON DILATATION CATHETER
• Common Device Name: RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
• Manufacturer (Section D): MERIL LIFE SCIENCES PVT. LTD; bilakhia house; muktanand marg, chala; vapi, gujarat 39619 1; IN 396191
• MDR Report Key: 7048999
• Report Number: 3009613036-2017-00003
• Device Sequence Number: 16458863
• Product Code: LOX
• UDI-Device Identifier: 18904224907697
• UDI-Public: 18904224907697
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

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: 02/23/2020
• Device Model Number: MOZ25009
• Device Catalogue Number: MOZ25009
• Device Lot Number: UMOA87
• 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: 10/13/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention