MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-08-01 for SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET K-J-SPPE-681710-ET manufactured by Cook Inc.
[115775811]
(b)(6). (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
[115775812]
It was reported, during a embryo transfer into the uterus procedure, when the doctor took the inner catheter of the soft-pass echotip embryo transfer catheter set out, they discovered the ecotip was missing. As reported, this patient has had previous embryo transfer procedures in the past and it was difficult to pass through the cervix, but in this case it was easy to get through the cervix. As reported, the embryo was sent to cryopreservation. The ecotip remains in the uterus and the patient is scheduled to have a minihysteroscopy on (b)(6) 2018 to have it removed. Requests were made for additional information regarding patient weight, all devices and/or medications utilized during the procedure, patient outcome post-procedure, and if there were any available photos, videos, imaging, or operative reports available, however the customer has not provided any further information. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02178 |
| MDR Report Key | 7739617 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-08-01 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2017-10-11 |
| Date Added to Maude | 2018-08-01 |
| 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 | SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET |
| Generic Name | MQF CATHETER, ASSISTED REPRODUCTION |
| Product Code | MQF |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2018-08-23 |
| Catalog Number | K-J-SPPE-681710-ET |
| Lot Number | 8283845 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-08-01 |