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 2018-05-18 for SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET K-J-SPPE-681210-ET manufactured by Cook Inc.
[108729864]
(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
[108729865]
It was reported that during an embryo transfer, the soft-pass echotip embryo transfer catheter set was used. During extraction of an empty catheter from the patient, that was inserted for a first trial, the tip of the transfer catheter was struck and as a result the metal part was detached and remained in the patient's uterus. During the extraction, the catheter extended beyond its normal length. The doctor decided to wait for the patient's menstruation to wash it out. Now it's out of the patient's body. The patient will need to come in for another embryo transfer procedure. 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 | 1820334-2018-01506 |
| MDR Report Key | 7526428 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-18 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2017-12-26 |
| Date Added to Maude | 2018-05-18 |
| 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 | 2018-05-18 |
| Returned To Mfg | 2018-05-29 |
| Catalog Number | K-J-SPPE-681210-ET |
| 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 | 2018-05-18 |