MAUDE Adverse Event Report: NUMED, INC. Z-MED II-X CATHETER; PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER

Model Number	305X
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Numed notified of this medwatch report by braun interventional systems.Braun interventional systems received the report from b.Braun medical.B.Braun medical received the report from the fda.The medwatch report contains very minimal information and there is no information as to who the user facility/initial reporter is.Numed is unable to even confirm this complaint.Based on the minimal information that was supplied in the user facility medwatch report, we can determine that this device was being used off-label.This device is only approved for pulmonary valvuloplasty and in the report it states that it was being used for balloon aortic valvuloplasty.A comparison catheter of the same catalog number was pulled and tested for burst pressure.The rated burst pressure for this size is 7 atm.The comparative catheter was inflated to rbp with no issues.It was then taken above the rbp and didn' burst until 11 atm, which is well above the labeled rated burst pressure for this device.
Event or Problem Description
Medwatch form received by bis from fda - "during balloon aortic valvuloplasty, the balloon initially inflated but ruptured.As a result, this balloon was removed and another balloon was inflated successfully.".

• Brand Name: Z-MED II-X CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 7048034
• Report Number: 1318694-2017-00028
• Device Sequence Number: 1069288
• Product Code: DQY
• UDI-Device Identifier: 04046964315848
• UDI-Public: 04046964315848
• Combination Product (Y/N): N
• PMA/510(K) Number: K022722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 305X
• Device Catalogue Number: PDZ733
• Device Lot Number: ZZX-1936
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1