MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-05 for SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET K-J-SPPE-681710-ET manufactured by Cook Inc.
[113187682]
(b)(6). 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
[113187683]
It was reported, during a oocyte transfer procedure as the soft-pass echotip embryo transfer catheter set was attempting to enter the cervix, the catheter bent. As reported, the echo tip catheter went around in the cervix twice, and when the speculum was removed, they noticed the echo tip in the vagina, the echo tip was removed from the vagina and then they noticed the tip was missing on the catheter. As reported, they waited for a full bladder, then they used a gynetics tulip embryo transfer device without complications. The device was destroyed and will not be returned. Patient outcome post-procedure, not pregnant. No adverse events have been reported as a result of the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01968 |
| MDR Report Key | 7663678 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-05 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-06-08 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2017-09-11 |
| Date Added to Maude | 2018-07-05 |
| 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 | 2018-07-05 |
| Returned To Mfg | 2018-07-10 |
| Catalog Number | K-J-SPPE-681710-ET |
| Lot Number | 8206744X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-05 |