MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-02 for GOLDSTEIN SONOHYSTEROGRAPHY CATHETER N/A J-GSHC-523620 manufactured by Cook Inc.
[37336160]
(b)(4). Event is still under investigation at this time.
Patient Sequence No: 1, Text Type: N, H10
[37336161]
At the end of an unknown procedure on a female patient of unknown age, the user was holding the catheter with swabs while removing the device. The rubber stopper slid off of the catheter in the patient. The physician was able to extricate the part from the patient. The customer stated it seemed there was not enough resistance for the rubber piece to stay on the device when removing. The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[49428849]
(b)(4). Investigation/evaluation during the course of the investigation, a review of the complaint history, quality control, instructions for use (ifu), and drawing of the product was conducted. The silicone positioner is checked to be at the correct location and the o. D. Of the positioner is checked per qc specifications. The product was not returned for a physical examination; however, it is stated within the provided ifu "upon removal of catheter, ensure that positioner is still on body of catheter. If still lodged in patient cervix, remove using forceps. " during the procedure should the positioner fall off of the catheter, the end user is instructed to remove the separated section with forceps. Based on the information provided and the results of our investigation, it is possible that force was applied; which may have resulted in the difficulty experienced. We will continue to monitor for similar complaints. Per the risk assessment (ra) no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[49428850]
At the end of an unknown procedure on a female patient of unknown age, the user was holding the catheter with swabs while removing the device. The rubber stopper slid off of the catheter in the patient. The physician was able to extricate the part from the patient. The customer stated it seemed there was not enough resistance for the rubber piece to stay on the device when removing. The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00041 |
| MDR Report Key | 5403684 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-02 |
| Date of Report | 2016-01-08 |
| Date of Event | 2016-01-08 |
| Date Facility Aware | 2016-01-08 |
| Date Mfgr Received | 2016-01-11 |
| Date Added to Maude | 2016-02-02 |
| 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 | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| 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 | 2016-02-02 |
| Model Number | N/A |
| Catalog Number | J-GSHC-523620 |
| ID Number | N/A |
| 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. Required No Informationntervention | 2016-02-02 |