MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,study,user faci report with the FDA on 2019-05-10 for COOK CERVICAL RIPENING BALLOON W/STYLET G19891 J-CRBS-184000 manufactured by Cook Inc.
[144721427]
As reported, the patient underwent placement of an optease vena cava filter. The indication for the filter placement was not reported. The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to perforation and tilt. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed. The optease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated. The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart. Without images or procedural films for review, the reported filter tilt and perforation events could not be confirmed and the exact cause could not be determined. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Additionally, the timing and mechanism of the filter tilt is unknown. It is unknown if the tilt contributed to the reported perforation. A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters. Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place. Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation. Clinical factors that may have influenced the event include the patient? S pre-existing co-morbidities, pharmacological issues and lesion characteristics. Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[144721428]
It is reported in a study of methods of labor induction the patient was randomized to induction using a cook cervical ripening balloon w/stylet. When the cook cervical ripening balloon was removed, an artificial rupture of membranes was performed and meconium stained fluid was noted. The patient then experienced abnormal cardiotocogram tracing and failure to progress in labor. These events led to a category 2 emergency cesarean section delivery. The cesarean delivery and meconium stained fluid led to prolonged hospital stay. The provider (chief investigator) reported that there is no causal relationship between the cook cervical ripening balloon w/stylet and the meconium stained fluid, failure to progress in labor, abnormal cardiotocogram tracing, and resulting emergency cesarean delivery. No additional consequences have been reported as occurring. Additional details have been requested regarding the patient and event. At this time, no information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01047 |
| MDR Report Key | 8600186 |
| Report Source | FOREIGN,OTHER,STUDY,USER FACI |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-01-26 |
| Date Mfgr Received | 2019-05-23 |
| Device Manufacturer Date | 2018-11-15 |
| Date Added to Maude | 2019-05-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 CERVICAL RIPENING BALLOON W/STYLET |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2019-05-10 |
| Model Number | G19891 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | 9313833 |
| 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 | 1. Hospitalization; 2. Other | 2019-05-10 |