MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-04-07 for GOLDSTEIN SONOBIOPSY CATHETER N/A J-GSBX-072026 manufactured by Cook Inc.
[42094404]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[42094485]
According to the initial reporter, after placement of a goldstein sonobiopsy catheter on a female patient of an unknown age, the cone of the catheter became separated and remained in the patient until it was found several days later by the patient's husband. Additional information has been requested, however it was not provided by the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[58620908]
(b)(4). Initial was filed within the 30 day time frame regardless of corrected date. Investigation - evaluation: a review of the complaint history, instructions for use (ifu), and quality control of the device was conducted during the investigation. The device is shipped with an ifu that describes the intended use, specific items are addressed such as: upon removal of the catheter, ensure that positioner is still on body of catheter. If still lodged in patient cervix, remove using forceps. " the complaint device was not returned therefore, no physical examinations could be performed. 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. As instructions are provided to confirm removal of the positioner from within the patient cervix, the root cause has been determined to be product use as the end user did not follow the instructions provided with the product. We will continue to monitor for similar complaints. Per the risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[58620909]
According to the initial reporter, after placement of a goldstein sonobiopsy catheter on a female patient of an unknown age, the cone of the catheter became separated and remained in the patient until it was found several days later by the patient? S husband. Additional information has been requested, however it was not provided by the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00220 |
| MDR Report Key | 5555205 |
| Report Source | USER FACILITY |
| Date Received | 2016-04-07 |
| Date of Report | 2016-03-16 |
| Date Mfgr Received | 2016-03-16 |
| Date Added to Maude | 2016-04-07 |
| 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 | 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 SONOBIOPSY CATHETER |
| Generic Name | HFF ASPIRATOR, ENDOMETRIAL |
| Product Code | HFF |
| Date Received | 2016-04-07 |
| Model Number | N/A |
| Catalog Number | J-GSBX-072026 |
| 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 | 2016-04-07 |