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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN

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COOK INC UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888)
Event Date 07/18/2019
Event Type  Death  
Manufacturer Narrative
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.
 
Event Description
"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).
 
Manufacturer Narrative
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.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
Manufacturer Narrative
Investigation ¿ evaluation it was reported in a journal article (percutaneous lung biopsy in immunocompromised pediatric patients, 2019) that either 16-20 g quick core biopsy needle or 20-25g chiba needle was used to perform biopsies and fine needle aspirations on various immunocompromised pediatric patients. Further communication with the authors clarified that the devices were not believed to have contributed to the complications, and that no product malfunctions were experienced. This investigation is for the eighth patient. The patient in this complaint expired due to nonspecific lung injury. A review of the complaint history, device history record, instructions for use (ifu), and quality control of the device were conducted during the investigation. The complaint device was not returned. Therefore, no physical examinations could be performed. However, a document based investigation evaluation was performed. Sufficient controls are in place to detect nonconforming product prior to release. The risks of both product families are acceptable when weighed against the benefits. No instructions for use (ifu) are provided with the chiba biopsy needle. Instruction for use shipped with the quick core biopsy needle provides the following information to the user related to the reported failure mode: "intended use the product is intended for use by physicians trained and experiences in diagnostic and interventional techniques. Standard techniques for soft tissue biopsy should be employed. " the device history record could not be reviewed due to lack of lot information from the user facility. The date of each complication described in the journal article occurred at an unspecified date between june 2000 and april 2017. Cook reviewed sales records to the user facility from 01jan2014 and 30apr2017 and could not sufficiently narrow down the lot number. Thus, the lot number remains unknown. Additional complaints were opened from the same journal article, but all of the lot numbers regarding each complaint are unknown. Since potential nonconformances or other complaints from the complaint device¿s lot could not be confirmed, there is no evidence that nonconforming product exists in house or in the field. Based on the review of the device master record and device history record as well as customer testimony, it was concluded the device was manufactured within specification. Per follow-up communication with the journal authors, no device malfunctions were alleged and the complications described were unrelated to use of the devices. Based on the information provided, no returned device, and the results of the investigation, it was concluded that no problem was detected with the device. The appropriate personnel have been notified. Cook will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
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Brand NameUNKNOWN
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9649332
MDR Text Key177045671
Report Number1820334-2020-00253
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/30/2020 Patient Sequence Number: 1
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