MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET G30399 J-SPPE-681710-ET-MC manufactured by Cook Inc.
[140916214]
(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
[140916215]
It is reported while performing a measurement in preparation for embryo transfer using an embryo transfer catheter assist device (rpnj-sppe-681710-et-mc) the echo tip band became caught in the outer catheter. Prior to embryo transfer, the physician reports using the embryo transfer catheter assist device (rpnj-sppe-681710-et-mc) to measure where the embryo would be placed. While removing the catheter from the outer sheath, the physician reported "the echo tip band became caught in the outer catheter. A great deal of force was required to separate them. Metal echo tip dislodged from the inner catheter and stuck onto outer catheter " a second soft-pass echo tip embryo transfer catheter set (k-j-sppe-681710-et) was used to complete the measurement prior to embryo transfer without difficulty. After successful measurement, the embryo transfer was completed using a soft-pass echo tip embryo transfer catheter set (k-j-sppe-681710-et). It is reported that the patient did not experience any adverse effects or require any additional procedures as a result of this alleged product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00671 |
| MDR Report Key | 8480402 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-04-23 |
| Device Manufacturer Date | 2019-01-25 |
| Date Added to Maude | 2019-04-03 |
| 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 |
| 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 | 0 |
| Brand Name | SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET |
| Generic Name | MFD CANNULA, INTRAUTERINE INSEMINATION |
| Product Code | MFD |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-03-27 |
| Model Number | G30399 |
| Catalog Number | J-SPPE-681710-ET-MC |
| Lot Number | 9474562 |
| 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 | 2019-04-03 |