MAUDE Adverse Event Report: NUMED, INC. MINI GHOST CATHETER; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 507

Device Problems Break (1069); Melted (1385); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

As per the report from the facility, the device was taken well above the labeled rated burst pressure.They stated that they took the balloon up to 30atm and it broke.The labeled rated burst pressure for this device is 20 atm.This device is approved for angioplasty of the femoral, renal and iliac arteries.They were using it for angioplasty of the pulmonary artery.This device is contraindicated for coronary arteries.The catheter was returned to numed for review.It was returned along with the sheath and the guidewire.The catheter was still in the introducer.The section of the shaft protruding from the distal end of the introducer is wrinkled.There is a detached section of the inner tubing on the guidewire.The balloon has torn laterally.The proximal end of the balloon is attached to the outer tubing.The distal end of the balloon has not been returned.The balloon was examined at 10x magnification.Nothing was observed that would have caused the balloon burst.The device history records were reviewed and no issues were identified.All devices that were distributed met the criteria for release and passed all inspection processes and procedures.There have been no other complaints with this catheter lot.A review of the balloon tubing used to manufacture this device was also performed.There were no other associated complaints with this lof of balloon tubing.A comparative device was pulled and tested for rated burst pressure.This device was the same balloon size and catalog number, but a different lot number.The balloon was immersed in a body temperature water bath and inflated until failure.The balloon burst at 21 atm, which is above the labeled rated burst pressure of 20 atm.

Event Description

As per the report from the distributor / hospital - we went up to 30 atm and it just broke.We got half of the balloon out and then continued to pull out pieces after.The surgeon got the bigger piece out of the subclavian.It looked like it had melted onto the guidewire.The balloon ruptured both circumferentially and longitudinally.The physician was using the balloon for angioplasty right pulmonary artery.An inflation device with pressure gauge was used - merit gauge basic compact inflation syringe - 30atm.The size and type of introducer sheath used was a 4f 45 chb performer sheath; the cook abbot workhorse.018 x 200 flex t guidewire was used.The catheter shaft was not kinked.The patient has a congenital defect - tetralogy of fallot.The patient condition post procedure was stable.A second balloon was not used to complete the procedure.

• Brand Name: MINI GHOST CATHETER
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 9304814
• MDR Text Key: 166519191
• Report Number: 1318694-2019-00023
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04046964341243
• UDI-Public: 04046964341243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 507
• Device Catalogue Number: MG132
• Device Lot Number: MG-2597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• 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
• Patient Age: 7 MO
• Patient Weight: 5