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

Model Number MOZ25014

Device Problems Patient-Device Incompatibility (2682); Difficult to Advance (2920); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

Unable to get balloon to cross over lesion.

Event 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
• Type of Device: 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
• Manufacturer (Section G): MERIL LIFE SCIENCES PVT. LTD.; bilakhia house, survey no. 135; muktanand marg, chala, vapi 39619 1; IN 396191
• Manufacturer Contact: narendra patel ; bilakhia house, survey no. 135; muktanand marg, chala, vapi 39619-1 ; IN 396191
• MDR Report Key: 7045108
• MDR Text Key: 93199511
• Report Number: 3009613036-2017-00002
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18904224907703
• UDI-Public: 18904224907703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2020
• Device Model Number: MOZ25014
• Device Catalogue Number: MOZ25014
• Device Lot Number: UMOA84
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/20/2017
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention