MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-26 for REPROCESSED SOUNDSTAR ECO CATHETER R10439072 manufactured by Sterilmed, Inc..
[139878533]
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. The device history record (dhr) was reviewed and no discrepancies were noted. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139878534]
It was reported that a patient underwent an atrial fibrillation procedure with a reprocessed soundstar eco catheter and the catheter was noticed to have dried blood on it. Prior to the blood being noticed, the reprocessed catheter was connected to the ultrasound machine and a message displayed that the probe was not supported. A new swiftlink was used, however, the issue remained and the message on ultrasound was displayed again. The catheter was replaced, the issue resolved. The imaging issue was discovered before the case began and during troubleshooting, groin access was being achieved. As the reprocessed catheter was taken away, it was examined and there was dried blood on the end of the catheter. Other catheters went into the body during the time before cleaning the entire sterile field and removing any potentially compromised items, therefore, other opened catheters were contaminated. All catheters were replaced. The reprocessed catheter never entered the patient? S body, but it was in the sterile field and the distal portion was near the patient? S groin. It is unknown at what point the blood got onto the catheter; if it was from groin access on the patient and dried before it was presented or if it came from the packaging with the dried blood. There were no patient consequences. The error message is not mdr reportable as this is highly detectable and poses no risk to the patient. However, since it is unknown where the blood came from, this event is being conservatively reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2019-00120 |
| MDR Report Key | 8452692 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-26 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-04-17 |
| Device Manufacturer Date | 2018-12-13 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 9497898687 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPROCESSED SOUNDSTAR ECO CATHETER |
| Generic Name | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2019-03-26 |
| Catalog Number | R10439072 |
| Lot Number | 2085656 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-26 |