MAUDE Adverse Event Report: NUMED CANADA, INC. NUCLEUS; PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER

Model Number 230

Device Problem Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

The balloon burst was confirmed.Two comparative catheters were tested for rated burst pressure.The labeled rbp for this catheter is 4.0 atm.The comparative catheters were taken to 8.0 atm and 7.0 atm, respectively, before burst.The user facility stated that they did not use an inflation device with pressure gauge to inflate this balloon as is recommended in the instructions for use.Due to them not using an inflation device with pressure gauge, it is unknown as to what pressure they took the balloon to.It is likely the balloon burst due to over inflation.The balloon was inflated with 17.5ml of dye.Hospital stated this volume was according to company booklet (instructions for use).However, numed does not recommend nor provide a volume chart for this product.The instructions for use states to use an inflation device with pressure gauge and lists rated burst pressures for this catheter.The patient is doing fine.

Event Description

As reported by baylis medical: " dr.(b)(6) was using the nucleus balloon for aortic valvuloplasty for pre-tavi procedure, they uses 17.5 ml of dye to inflate the balloon.During the inflation of the aortic valve, the balloon ruptured and he los 2/3 of the balloon into the patient which they never found.Balloon ruptured and they lost pieces in the body that they didn't find.".

• Brand Name: NUCLEUS
• Type of Device: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED CANADA, INC.; 45 second street west; cornwall, ontario K6J 1 G3; CA K6J 1G3
• Manufacturer (Section G): NUMED CANADA, INC.; 45 second street west; cornwall, ontario K6J 1 G3; CA K6J 1G3
• Manufacturer Contact: melissa thomas ; 45 second street west; cornwall, ontario K6J 1-G3 ; CA K6J 1G3 ; 9362592
• MDR Report Key: 6581056
• MDR Text Key: 75605223
• Report Number: 9618000-2017-00001
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2021
• Device Model Number: 230
• Device Catalogue Number: PVN230
• Device Lot Number: Y-5872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• 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: 68 YR
• Patient Weight: 124