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

Model Number	MOZ25014
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to get balloon to cross over lesion.
Event or Problem Description
Physician was unable to advance the device through or past the target lesion.He said it was a little bulky and the patient had very tortuous vessels.He was able to get a competitor balloon of the same size to cross lesion and work well.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: 7045108
• Report Number: 3009613036-2017-00002
• Device Sequence Number: 2144934
• Product Code: LOX
• UDI-Device Identifier: 18904224907703
• UDI-Public: 18904224907703
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 02/20/2020
• Device Model Number: MOZ25014
• Device Catalogue Number: MOZ25014
• Device Lot Number: UMOA84
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/20/2017
• 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