MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for SELECTIVE SALPINGOGRAPHY CATHETER J-SSG-554086 manufactured by Cook Inc.
[117462575]
(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
[117462576]
It was reported, during a hydrotubation, the operator inserted the selective salpingography catheter into the 22? Hysteroscope by hand. The catheter could not move forward after it was inserted about 2 centimeters (cm). The operator withdrew the catheter and found the end tip of the catheter was broken off. Requests were made for additional information regarding further details of the event, however, the customer has not provided any further information. No adverse events have been reported as a result of the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02442 |
| MDR Report Key | 7790079 |
| Date Received | 2018-08-16 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2017-06-19 |
| Date Added to Maude | 2018-08-16 |
| 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 | SELECTIVE SALPINGOGRAPHY CATHETER |
| Generic Name | MOV CATHETER, SALPINGOGRAPHY |
| Product Code | MOV |
| Date Received | 2018-08-16 |
| Returned To Mfg | 2018-08-16 |
| Catalog Number | J-SSG-554086 |
| Lot Number | 8001113 |
| 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 | 2018-08-16 |