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 2018-04-23 for SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET K-J-SPPE-681700-ET manufactured by Cook Inc.
[106632944]
(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
[106632945]
It was reported that at the time of making an embryo transfer, the echotip from the soft-pass echotip embryo transfer catheter set had detached and was left inside the patient. The echotip from the catheter was not retrieved. The doctor stated that the catheter had been reused by his assistant. Per the instructions for use (ifu) the device is intended for one-time use. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01190 |
| MDR Report Key | 7451936 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-23 |
| Date of Report | 2018-08-31 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2018-08-23 |
| Device Manufacturer Date | 2017-02-15 |
| Date Added to Maude | 2018-04-23 |
| 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 | 3 |
| Brand Name | SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET |
| Generic Name | MQF CATHETER, ASSISTED REPRODUCTION |
| Product Code | MQF |
| Date Received | 2018-04-23 |
| Catalog Number | K-J-SPPE-681700-ET |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-23 |