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

Model Number	MOZ20015
Medical Device Problem Codes	Off-Label Use (1494); Device Slipped (1584); Device Issue (2379); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Human Factors Issue (2948); Physical Property Issue (3008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information under good faith effort.But, neither the device specific lot number was provided nor was the concomitant product returned.Thus, a complaint investigation could not be performed.However, further investigation will be performed if the lot number or the associated device is received.Meril shall submit a supplement report accordingly.
Event or Problem Description
The tip of the balloon came off while trying to reload the balloon on the wire for a second inflation.

• 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, survey no. 135; muktanand marg; chala, vapi 39619 1; IN 396191
• MDR Report Key: 7432832
• Report Number: 3009613036-2018-00009
• Device Sequence Number: 13807310
• Product Code: LOX
• UDI-Device Identifier: 18904224907598
• UDI-Public: 18904224907598
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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 Model Number: MOZ20015
• Device Catalogue Number: MOZ20015
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1