MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-21 for GOLDSTEIN SONOHYSTEROGRAPHY CATHETER J-GSHC-532600 manufactured by Cook Inc.
[121046669]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[121046670]
It was reported, the patient underwent a sonohystogram where the goldstein sonohysterography catheter was used. When the device was removed the cone remained in the patient and the physician could not locate the cone. On (b)(6) 2018 a hysteroscopy was performed on the patient and the cone was in the patient. The physician performed another sonohystogram after the hysteroscopy and the cavity seemed clear. The ultrasound manager pulled the sonohystogram device back to the cervix and still could not locate the cone. Additional information has been requested regarding the patient and the event. At the time of this report, no further information has been provided. Per the instructions for use (ifu) that accompanies this device: catheter is removed upon completion of ultrasound procedure. Upon removal of catheter, ensure that positioner is still on body of catheter. If still lodged in patient cervix, remove using forceps. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02780 |
| MDR Report Key | 7898625 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-21 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-08-27 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-09-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLDSTEIN SONOHYSTEROGRAPHY CATHETER |
| Generic Name | HFF ASPIRATOR, ENDOMETRIAL |
| Product Code | HFF |
| Date Received | 2018-09-21 |
| Catalog Number | J-GSHC-532600 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-09-21 |