MAUDE Adverse Event Report: NUMED CANADA, INC. NUCLEUS; BALLOON AORTIC VALVULOPLASTY CATHETER

Model Number 230

Device Problems Entrapment of Device (1212); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

Catheter not returned for review.Review of production records showed no issues and that all catheters in this lot (33) met all requirements for release.There have no other complaints associated with this lot number.A review of the balloon tubing used to manufacture the balloons in this lot of catheters was also performed.1,147 pieces of tubing were issued in lot number 103017g.No other complaints have been received on this balloon tubing lot number.Trending of complaint information shows that there have been a total of 8 balloon burst complaints since the introduction of this catheter on to the market in 1999.With sales totalling 79,442 devices from 1999 through the end of august 2019, this represents a complaint percentage of only 0.01%.A reject catheter was pulled for comparative testing, this catheter was rejected for foreign matter under sheath.Lot# y-5503 pvn229 18x4x10x8x110x.035 labeled rated burst pressure of 4.0 atm.Vp of r&d; ted dominy, tested this catheter september 20/2019, the results are below: the balloon was inflated in a body temperature water bath.Diameters were taken at 1 atm intervals.The pressure/diameter measurements were: atm, diameter, 1.0, 16.74 mm, 2.0, 17.28 mm, 3.0, 17.68 mm, 4.0, 18.22 mm, 5.0, 18.70 mm, 6.0, 18.96 mm, 7.0, 19.30 mm, 8.0, 19.72 mm, 9.0, burst.The balloon had a longitudinal tear at 9 atm, which is well above the labeled rated burst pressure of 4.0 atm.At this time, it is unknown as to what caused the balloon to burst.The additional questions asked would provide numbed with additional information for the investigation, but they have not been answered.All reviews and testing performed showed no issues with the nucleus catheter.

Event Description

As per the report from the foreign user facility and distributor - rupture of the balloon during inflation in the aortic valve.Uncoupling of the inner membrane from the balloon shaft that hit the guide.Impossible to remove the balloon and guide from femoral artery.Sent to surgery.Balloon destroyed by the service.

• Brand Name: NUCLEUS
• Type of Device: BALLOON AORTIC VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED CANADA, INC.; 45 second street west; cornwall, K6J 1 G3; CA K6J 1G3
• Manufacturer (Section G): NUMED CANADA, INC.; 45 second street west; cornwall, K6J 1 G3; CA K6J 1G3
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 9119558
• MDR Text Key: 165035661
• Report Number: 9618000-2019-00008
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 230
• Device Catalogue Number: PVN229
• Device Lot Number: Y-6832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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