MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-01-30 for UNKNOWN manufactured by Cook Inc.
[177045671]
Patient is either (b)(6) or (b)(6) years old, per article. Likely there is an entry error in the table indicating (b)(6) years old. The text indicates (b)(6) years old on two occasions. Date of event: data collected from june 2000 to april 2017. Suspect medical device: unknown 16-20 g quick core biopsy needle or 20-25g chiba needle. Common device name: unknown. Initial reporter also sent report to fda: unknown. 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
[177045672]
"procedures were performed after preprocedure noncontrast chest computed tomography (ct) (n =73). Lesions were either pleural (n =61) or parenchymal (n =12) based. Pleural-based lesions were defined as having contact with the pleural surface. " "the preprocedural cross-sectional imaging for each patient was reviewed to determine the optimal positioning and approach for percutaneous biopsy. The choice of needle, gauge (20 g), throw length, number of passes (standard of 4 passes, 2 fnas, and 2 core samples), and technique (coaxial vs. Tandem needle) was determined at the time of the procedure by the pediatric interventional radiologist. Lesion sizes (ranging from 10? 40 mm, based on the longest axis of the lesion), location (central, nonpleural-based vs. Peripheral, pleural-based), and presence of consolidation (ill-defined homogeneous opacities with obscuration of vessels and alveolar air bronchograms vs. Lesions with some ground glass components) were determined based on preprocedural or intraoperative imaging. " "ultrasonography-guided biopsies were performed using free-hand technique, with placement of the ultrasonography probe along the longest axis of the lesion at the most appropriate intercostal space. All procedures were performed during the respiratory phase allowing for the best visualization of the lesion, most often at end-expiration (n = 39). All lesions were biopsied through the pleural surface. In ct-guided biopsies, patients were positioned according to the optimal approach based on preprocedural imaging. Patient positioning included prone (n = 18), supine(n = 6), and right lateral decubitus (n = 3). All biopsies were performed using coaxial needle technique (median passes, 5; range, 1? 20). Tract embolization was not performed. A chest radiograph of all patients was taken 2 hours after the procedure to assess for complications. If patients showed signs and symptoms of complications such as pneumothorax or bleeding, the imaging interval was shortened. When biopsies were preformed using ct guidance, a postprocedural chest ct was obtained immediately after needle removal to assess for complications. " "procedures were performed with the patient under monitored anesthesia care (n = 25, 34%) or general anesthesia (n = 48, 66%). Core biopsy samples were obtained with 16-g to 20-g cook (n = 38; cook medical, (b)(4)) and [another manufacturer's biopsy needle] (n = 35) devices. Fna was performed using 20-g to 25-g chiba needles (n = 18; cook medical). When 5 fna passes were performed, the median was 6 passes (range, 5? 20 passes). When 4 fna passes were performed, the median was 4 passes (range, 1? 4). Core biopsies alone were obtained in a majority of the cases (n = 55, 75%). Fna was performed in conjunction with core needle biopsy (n = 18, 22%) beginning in 2013. " "a total of 8 major complications (10%) (refer to table 3) occurred, including pneumothorax requiring chest tube placement (n = 3) (sir categories c and d); hemoptysis requiring extended intubation, and intensive care unit care (n = 3) (sir categories c and d) and death (n = 2) (sir category f) from respiratory arrest presumably secondary to asphyxiation from pulmonary hemorrhage. The histological diagnosis was determined to be caused by infection in 5 of 8 patients (63%) with major complications. Six of the 8 patients (75%) with major complications had biopsies performed with fna, of which 4 were found to be inconclusive. " patient #8, "a (b)(6)-year-old boy with a history of relapsed acute lymphoblastic leukemia underwent biopsy to evaluate suspected multifocal pneumonia that had worsened despite prolonged antibacterial and antifungal therapy. The patient died and was found to have nonspecific acute lung injury, with a diagnosis that was never able to be precisely determined on autopsy. " "in both of the present patients? Deaths, massive periprocedural pulmonary hemorrhage leading to cardiopulmonary arrest was the principal cause of death. Although no diagnosis was ever obtained in the (b)(6)-year-old patient ((b)(6)) , an autopsy performed on the (b)(6)-year old child ((b)(6)) affirmed angio-invasive pneumocystis fungi. " the eight major complications mentioned above are captured in reports with patient identifiers (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[184894368]
Patient confirmed to be (b)(6). 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
[184894369]
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00253 |
| MDR Report Key | 9649332 |
| Report Source | LITERATURE |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-07-18 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| 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 | UNKNOWN |
| Product Code | FCG |
| Date Received | 2020-01-30 |
| Catalog 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 | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-30 |