MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for EP CATHETER DIAGNOSTIC POLARIS X STEERABLE DECAPOLAR 270DEG STANDARD EPT7005D manufactured by Sterilmed, Inc..
[146383904]
At the time of this submission, the device has not yet been returned for investigation. However, photographs of the device issue were received. The provided photographs show the distal section of an unidentifiable ep catheter device, outside of any type of packaging. There are no observed contaminants on the device indicating use or exposure in the field. There is an observed separation at a transition point along the catheter shaft, exposing the internal electrical wires. The electrical wires appeared to be intact (no wires protruding out). The transition point appears to be a connection joint between the distal section of the shaft containing the electrodes and the remaining proximal section of the shaft. It is not determined from the photograph whether this is due to a failure of a bond between these two sections or if this should be one whole continuous piece. In the photograph, there is a sterilmed label nearby, partially obscured by packing wrap. The information appears to match the reported device information and lot number reported. However, while the provided media file is viewable, as there are other decapolar ep catheters with similar color shafts, there is no determination that the device in the photograph is the reported involved device, an ep technologies device, the associated model ept7005d or even a reprocessed device, since there? S no evidence of a sterilmed reprocessing logo, stamp, marking or flag label to verify it is sterilmed product. Thus, the reported complaint condition cannot be confirmed. As well, as device was removed from its packaging and used in the reported procedure, possible causes for this observed condition could be mishandling subsequent to distribution, including shipping/storage conditions or improper manipulation of the catheter. The instructions for use (ifu) states: "inspect package and product and do not use the device if damage is noted or sterility appears to be compromised. " "careful manipulation must be performed in order to avoid cardiac damage, perforation or tamponade. Catheter advancement and placement should be done under fluoroscopic guidance through a guiding sheath. Do not use excessive force to advance or withdraw the catheter through the guiding sheath, when resistance is encountered. In addition, extra care should be taken while inserting, aspirating and manipulating the guiding sheath. " "never manipulate the? Deflectable section of the shaft while within the introducer". A review of the device history record found that the devices reprocessed under lot# 2078149 passed all necessary visual and functional criteria prior to being distributed to customers. A manufacturing record evaluation was performed for the finished device lot# 2078149, and no non-conformance's were identified. Once device is received, a complete evaluation will be conducted. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146383905]
It was reported that a patient underwent an atrial flutter procedure with an ep catheter diagnostic polaris x steerable decapolar 270deg standard catheter, and the tip became partially separated from the shaft. After the device was removed the patient, it was noticed that the tip was separated from the shaft and internal components were exposed which held the catheter tip to the shaft to prevent a full separation. There was no delay, medical intervention or patient consequence. The procedure was canceled due to non-induction because the patient was in atrial fibrillation and did not actually have a flutter. This cancellation was unrelated to the catheter issue. This event has been assessed as a reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2019-00134 |
| MDR Report Key | 8580255 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-06-06 |
| Device Manufacturer Date | 2018-11-29 |
| Date Added to Maude | 2019-05-03 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497898687 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EP CATHETER DIAGNOSTIC POLARIS X STEERABLE DECAPOLAR 270DEG STANDARD |
| Generic Name | CATHETER, RECORDING, ELECTRODE, REPROCESSED |
| Product Code | NLH |
| Date Received | 2019-05-03 |
| Returned To Mfg | 2019-06-06 |
| Catalog Number | EPT7005D |
| Lot Number | 2078149 |
| Device Expiration Date | 2019-11-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |