MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-04-03 for UNKNOWN BIOPSY FORCEPS UNK-BIOPSYFORCEPS manufactured by Cordis Corporation.
[140768478]
This article was found during a recent literature search of this device. Please note that patient specific details (demographics, medical history, and reason for intervention) are not available. The device is cordis biopsy forceps but the catalog and lot numbers are not available. A copy of the publication is attached to this report. The citation is as follows: amitai et al. (2007). "comparison of three-dimensional echocardiography to two-dimensional echocardiography and fluoroscopy for monitoring of endomyocardial biopsy. " the american journal of cardiology. Am j cardiol; 99: 64? 866, doi: 10. 1016/j. Amjcard. 2006. 10. 050. As reported in the literature article by amitai et al. , (2007). "comparison of three-dimensional echocardiography to two-dimensional echocardiography and fluoroscopy for monitoring of endomyocardial biopsy. " the american journal of cardiology. Am j cardiol; 99: 864? 866, doi: 10. 1016/j. Amjcard. 2006. 10. 050; during an endomyocardial biopsy (emb) procedure using cordis disposable bioptomes, one clinical complication occurred with documented perforation that resulted in cardiac tamponade. The device was not returned for analysis. Additionally, as the sterile lot number was not available, device history record (dhr) reviews could not be performed. Given the limited information provided, the reported events? Perforation? And? Cardiac tamponade? Could not be confirmed and the exact root cause could not be determined. According to the instructions for use (ifu), procedures requiring biopsy forceps should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure and are listed on the ifu. Possible complications include but are not limited to; hematoma at the puncture site, infection, perforation of the vessel wall or the myocardium, vessel trauma, embolism, and death. Cardiac tamponade is a serious medical condition in which blood or fluids fill the space between the sac that encases the heart and the heart muscle. This places extreme pressure on your heart. The pressure prevents the heart's ventricles from expanding fully and keeps your heart from functioning properly. Vessel perforation may cause cardiac tamponade, as was reported in this case. Additionally, vessel characteristics and procedural/handling factors may have contributed to the reported event. Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process. Therefore, no preventative or corrective actions will be taken at this time. This is one of two products involved with the same literature article and the associated manufacturer report number is 1016427-2019-02680.
Patient Sequence No: 1, Text Type: N, H10
[140768479]
As reported in the literature article by amitai et al. , (2007). "comparison of three-dimensional echocardiography to two-dimensional echocardiography and fluoroscopy for monitoring of endomyocardial biopsy. " the american journal of cardiology. Am j cardiol; 99: 864? 866, doi: 10. 1016/j. Amjcard. 2006. 10. 050; during an endomyocardial biopsy (emb) procedure using cordis disposable bioptomes, one clinical complication occurred with documented perforation that resulted in cardiac tamponade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1016427-2019-02681 |
| MDR Report Key | 8478378 |
| Report Source | LITERATURE |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2007-01-01 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-03 |
| 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 | KARLA CASTRO |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863138372 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN BIOPSY FORCEPS |
| Generic Name | DEVICE, BIOPSY, ENDOMYOCARDIAL |
| Product Code | DWZ |
| Date Received | 2019-04-03 |
| Catalog Number | UNK-BIOPSYFORCEPS |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 14201 NW 60 AVENUE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-04-03 |