MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2018-02-08 for Z-MED CATHETER 302 PDZ320 manufactured by Numed, Inc..
[99365514]
The device was not returned to numed for evaluation. Through additional communications with the facility it was learned that the device was being used off-label for an unapproved use. It was also stated that the catheter inflated and deflated without issue. From the wording used in the report, it sounds like the catheter was not fully deflated before being pulled back into the introducer which caused the balloon to catch and tear apart. The instructions for use this catheter is approved for valvuloplasty of the pulmonary and aortic valves. This was being used off-label for a re-dilation of a stent in the ivc. The instructions for use has the following warning: "the catheter is not intended for use with stents. " the instructions for use also include the following precautions: -if resistance is felt upon removal, then the balloon, guidewire, and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction. - before removing the catheter from the sheath it is very important that the balloon is completely deflated. A comparative catheter was pulled and tested for rated burst pressure as well as bond strength. It was the same catalog number as the complaint catheter. The catheter met all specifications for both the labeled rated burst pressure as well as bond strength.
Patient Sequence No: 1, Text Type: N, H10
[99365515]
As reported to numed - "reporting a malfunctioning angioplasty balloon. The balloon separated off of the shaft of the delivery system. The patient then had to endure another procedure and risk and time. " additional information received on 1/19/2018 - "the balloon was completely separated from the shaft. It was in two separate pieces when it came back out. The balloon was also ruptured and they had to snare out what was left behind before using a larger atlas gold 22 x 4 balloon to finish the procedure. They were unaware of the rupture and detachment until they pulled out the balloon and saw it. There was no video. A 260 cm cook lunderquist guidewire was used. The z-med was inside a stent in the ivc. A 12fr 13 cm cook flexor sheath was used. An inflation device with pressure gauge was used. The balloon ruptured circumferentially, however it was not during inflation or deflation. The catheter shaft was not kinked. There was nothing unusual about the patient anatomy. The patient was fine post procedure. " additional information received on 2/5/2018 - " the z-med was used to dilate a previously placed stent in the ivc. They inflated the balloon and deflated the balloon without problem. They believe the balloon ruptured/separated after deflation while being pulled back. They do not know what pressure they took it to. They did use fluoroscopy and saw that inflation and deflation went without rupture. When pulling the balloon back over the wire they noticed it was difficult to do so. At that point they checked the fluoro and noticed that the balloon was separated. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00002 |
| MDR Report Key | 7251833 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-08 |
| Date of Event | 2018-01-11 |
| Date Mfgr Received | 2018-01-12 |
| Device Manufacturer Date | 2017-04-12 |
| Date Added to Maude | 2018-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICHELLE LAFLESH |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal | 12965 |
| Manufacturer Phone | 3153284491 |
| Manufacturer G1 | NUMED, INC. |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Z-MED CATHETER |
| Generic Name | BALLOON AORTIC VALULOPLASTY CATHETER |
| Product Code | OZT |
| Date Received | 2018-02-08 |
| Model Number | 302 |
| Catalog Number | PDZ320 |
| Lot Number | Z-7300 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Manufacturer Address | 2880 MAIN STREET HOPKINTON NY 12965 US 12965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-08 |