MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-03 for GOLDSTEIN SONOHYSTEROGRAPHY CATHETER N/A J-GSHC-542600-SV manufactured by Cook Inc.
[51070107]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[51070108]
Per the mw5062932, reported through the fda voluntary event reporting process, the manufacturer was informed that the ob/gyn personnel inserted a saline infusion sonography catheter into the female patient for ultrasound. The device was removed and patient was sent home. The following day, the patient reported that a piece of white plastic fell out of her vagina. Patient returned to office to report and was very angry that a piece of the catheter was left in her to fall out. 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
[63941586]
(b)(4). Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications and trends was conducted during the investigation. The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. Review of device history record shows no nonconforming events which could contribute to this failure mode. The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: the "catheter is removed upon completion of ultrasound procedure. " the instructions for use also state "note: upon removal of catheter, ensure that positioner is still on body of catheter. If still lodged in patient cervix, remove using forceps. " based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[63941587]
Per the mw5062932, reported through the fda voluntary event reporting process, the manufacturer was informed that the ob/gyn personnel inserted a saline infusion sonography catheter into the female patient for ultrasound. The device was removed and patient was sent home. The following day, the patient reported that a piece of white plastic fell out of her vagina. Patient returned to office to report and was very angry that a piece of the catheter was left in her to fall out. 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 | 1820334-2016-00693 |
| MDR Report Key | 5843993 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-03 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-06-03 |
| Date Mfgr Received | 2016-07-08 |
| Device Manufacturer Date | 2015-06-29 |
| Date Added to Maude | 2016-08-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2016-08-03 |
| Model Number | N/A |
| Catalog Number | J-GSHC-542600-SV |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-08-03 |