MAUDE Adverse Event Report: PAN MEDICAL US, CORP. INTERV; BALLOON CATHETER

Device Problem Material Rupture (1546)

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

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

There was no harm to the patient reported.This report is being submitted at this time because the previous owner of the company did not report this event at the time it occurred.The company has since come under new ownership and management, and therefore this complaint is now being reported, as it should have been at the time.

Event Description

A complaint was received from a distributor alleging that an interv balloon catheter had ruptured during a procedure.No injury to the patient was reported and attempts to contact the medical staff were unsuccessful.The unit was not re-returned to the manufacturer.

• Brand Name: INTERV
• Type of Device: BALLOON CATHETER
• Manufacturer (Section G): PAN MEDICAL US, CORP.; 7401 114th ave; bldg. v - suite 505; largo FL 33773
• Manufacturer Contact: peter traina ; 7401 114th ave.; bldg. v - suite 505; largo, FL 33773 ; 7279143932
• MDR Report Key: 8583667
• MDR Text Key: 146492610
• Report Number: 3011193469-2018-00001
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 95