MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-07 for TUOHY NEEDLE 1150-4M200 manufactured by Pajunk Gmbh Medizintechnologie.
[173875843]
Event took place in the us and has been reported through us distributor distribution subsidiary (b)(4). The event has been described initially by another manufacturer potentially involved, abbott. Currently the data is poor and the device has not been returned/ analysed. As soon as further data will be available a follow up report will be sent in to the agency. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[173875844]
(b)(4). Description provided by distributor: an adverse event report was received, in which your device was involved. Event description: during a ventricular tachycardia ablation procedure, a pleural effusion, cardiac arrest and subsequent death occurred. While attempting epicardial access, a pleural effusion was confirmed on ice at the rv apex, suggestive perforation from the pajunk needle. Epicardial access was confirmed with dye visualized layering around the pericardial space. A wire was then advanced and observed to curl in the epicardial space without advancing beyond the cardiac silhouette. An agilis sheath was then advanced over the wire into the pericardial space. A second wire was advanced into the epicardium. The agilis was removed and advanced over one of the wires. The wire and dilator were from the agilis and the remaining wire was secured to the drape. Approximately 290 cc of blood was removed from the pericardial space. The effusion did not reaccumulate and was closely monitored during the procedure. A coronary angiogram was completed afterwards. Following the ablation, the patient became hypotensive. Blood was visualized in the pericardial space. Chest compressions were initiated. A chest tube was placed and a blood was removed. The bleeding did not slow and ct surgery was called for ecmo. The rhythm degenerated and the patient chocked multiple times throughout. Sinus rhythm could not be restored. Surgery was performed and biv pacing was finally restored after heart paddle shock. Direct visualization of the heart showed the left-sided chest tube was puncturing the lv. The chest tube was removed and the myocardium was stitched. Bleeding could not cease and resuscitative efforts were abandoned. The patient was deceased. It was noted the patient was high-risk with comorbidities that contributed to the sequence of events. Before pericardial effusion, the catheter being used before the pajunk needle (#1150-4m200) was the abbott "catheter acunav" - #10135936. Event date: (b)(6) 2019. Account: (b)(6) hospital. Abbott received information from the field regarding the above event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611612-2020-00001 |
| MDR Report Key | 9556364 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-08-30 |
| Date Mfgr Received | 2020-01-03 |
| Date Added to Maude | 2020-01-07 |
| 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 CHRISTIAN QUASS |
| Manufacturer Street | KARL-HALL-STR. 1 TUTTLINGER STR. 7 |
| Manufacturer City | GEISINGEN, 78187 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78187 |
| Manufacturer G1 | PAJUNK GMBH MEDIZINTECHNOLOGIE |
| Manufacturer Street | KARL-HALL-STR. 1 TUTTLINGER STR. 7 |
| Manufacturer City | GEISINGEN, 78187 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78187 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUOHY NEEDLE |
| Generic Name | NERVE BLOCK NEEDLE, EPIDURAL, SINGLE SHOT AND CATHETER PLACEMENT |
| Product Code | BSP |
| Date Received | 2020-01-07 |
| Model Number | 1150-4M200 |
| Catalog Number | 1150-4M200 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PAJUNK GMBH MEDIZINTECHNOLOGIE |
| Manufacturer Address | KARL-HALL-STR. 1 TUTTLINGER STR. 7 GEISINGEN, 78187 GM 78187 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-07 |