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 2019-05-16 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER G17870 J-CHSG-703000 manufactured by Cook Inc.
[145240003]
(b)(46. Occupation: superintendent radiographer. 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
[145240004]
It was initially reported during a hysterosalpingogram (hsg) procedure this week 2 cook silicone balloon hysterosalpingography injection catheters once inflated did not deflate when required. Fortunately, the radiologist tested these catheters before patient use as this would have caused cervical shock if trying to remove with an inflated balloon. The patient's examinations had to be abandoned as we did not have an alternative. Additional information was received on 30apr2019 from the initial reporter. The number of patients involved was 2. The patients ages were approximately 37-40. Unable to provide information about patient's health & history. The procedures went ahead using alternative devices. The patients suffered no adverse effects as the balloon catheters were tested before use on the patients. This report is for the 2nd patient involved during the reported deflation failures. The 1st patient event is reported in mfr. Report # 1820334-2019-00814.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01114 |
| MDR Report Key | 8615648 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-16 |
| Date of Report | 2019-07-05 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-06-11 |
| Device Manufacturer Date | 2018-04-02 |
| Date Added to Maude | 2019-05-16 |
| 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 | 3 |
| Brand Name | COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER |
| Generic Name | HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES) |
| Product Code | HES |
| Date Received | 2019-05-16 |
| Model Number | G17870 |
| Catalog Number | J-CHSG-703000 |
| Lot Number | 8710019 |
| 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 | 2019-05-16 |