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.
[37335940]
(b)(4). Event is still under investigation at this time.
Patient Sequence No: 1, Text Type: N, H10
[37335941]
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 attempted to manually extricate the part however, due to pain due to other medical issues that the patient could not tolerate it. The patient went to the small procedures unit on (b)(6) 2015 to have the stopper removed; however, it was confirmed that the part had already exited the patient. It was confirmed that the patient is doing well. The customer stated it seemed there was not enough resistance for the rubber piece to stay on the device when removing.
Patient Sequence No: 1, Text Type: D, B5
[47967650]
(b)(4). **investigation** a review of complaint history, drawings, instruction for use (ifu), and quality control (qc) was conducted during the investigation. The product was not be returned; a physical examination could not be completed. The lot number is unknown. The silicone positioner is checked to be at the correct location and the o. D. Of the positioner is checked per qc. The i. D. Of the silicone positioner is checked using calipers and pin gages to have the proper diameter. The o. D. Of the tubing is checked using calipers to be within the proper diameter. With the o. D. Of the tubing at the low end of its tolerance, consider a worst case scenario in which the silicone positioner is on the high end of tolerances. The positioner is intended to be adjustable for positioning, therefore small movement of the positioner on the tubing is expected. It is highly unlikely the positioner would slide off the tubing without an extraneous force applied. It is stated within the ifu, upon removal of catheter, ensure that positioner is still on body of catheter. If still lodged in patient cervix, remove using forceps. Should the positioner fall off of the catheter during the procedure, the end user is instructed to remove the separated section with forceps. Since the product was not returned for a physical examination, the root cause has been determined to be customer dissatisfaction. The provided instructions for use caution that the silicone positioner may fall off during removal and provide instruction as to what to do in that situation. The appropriate internal personnel have been notified. We will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[47967651]
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 attempted to manually extricate the part however, due to pain due to other medical issues that the patient could not tolerate it. The patient went to the small procedures unit on (b)(6) 2015 to have the stopper removed; however, it was confirmed that the part had already exited the patient. It was confirmed that the patient is doing well. The customer stated it seemed there was not enough resistance for the rubber piece to stay on the device when removing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00013 |
| MDR Report Key | 5404194 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-02 |
| Date of Report | 2016-01-08 |
| Date of Event | 2015-12-28 |
| Date Facility Aware | 2015-12-28 |
| Date Mfgr Received | 2016-01-08 |
| 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 | 8123392235 |
| 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 |