|
|
| Model Number |
N/A |
| Medical Device Problem Code |
Adverse Event Without Identified Device or Use Problem (2993)
|
| Health Effect - Clinical Codes |
Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605); No Code Available (3191)
|
| Date of Event |
11/30/2018
|
|
Type of Reportable Event
|
Serious Injury
|
|
Additional Manufacturer Narrative
|
|
Concomitant medical products: self-expanding metallic stents, 22-g chiba needle (cook), 0.035 in guidewire, 5f headhunter or cobra catheter, 6f sheath, stiff 260cm x 0.035 inch guidewire, gelfoam platelets.Occupation: unknown.Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
|
| |
|
Event or Problem Description
|
|
The below description of a serious injury using a neff percutaneous access set was taken from the following article: zhou et al., "study of percutaneous stent placement with iodine-125 seed strand for malignant biliary obstruction.¿ cardiovascular and interventional radiology 42 (2018): 268-475.The following is stated in the article: "this study included 132 patients with moj (malignant obstructive jaundice) treated from november 2015 to october 2017.Forty-five patients underwent insertion of sems with iodine-125 seed strands (seeds group); the remaining 87 patients underwent sems placement alone (control group).Technical success was defined as accurate, successful deployment of sems with or without iodine-125 seed strand; clinical success was defined as 20% reduction in serum bilirubin within 1 week after the procedure, compared with baseline.Complications, duration of primary stent patency, and overall survival were evaluated." ¿procedures were performed under fluoroscopic guidance.The access site was chosen on the basis of pre-procedural images.The intrahepatic bile duct was punctured with a 22-g chiba needle, followed by insertion of a neff percutaneous access set.The outer cannula of the neff set was kept, and cholangiography was performed to evaluate the obstruction site.A 0.035-inch guidewire was then advanced, and the outer cannula of the neff set was exchanged with a 5-f headhunter or cobra catheter to cross the obstruction site.After measurement of the length of the stricture, a long 5-f sheath was advanced over the guidewire to the duodenum; the guidewire was kept within the sheath.A stiff guidewire 260 cm long and 0.035 inches in diameter was inserted through the sheath to the distal duodenum." "after the stricture was crossed, a 6-f sheath was introduced over the 0.035-inch guidewire.Then, an uncovered sem was inserted through the sheath and delivered across the stricture.Cholangiography was performed to verify stent patency.The puncture approach was occluded with gelfoam pledgets.¿ "technical success was achieved in all patients in both groups." "all patients were regularly followed up through (b)(6) 2018 or until patient death.The follow-up visits included outpatient and telephone interviews.Telephone interviews were performed at 2 weeks and then every 3 months after stent placement.Outpatient interviews were performed 1 month after stent implantation.If obstructive jaundice recurred (confirmed elevation of bilirubin level and dilatation of bile ducts on ct), the patient was encouraged to undergo stent revision or external drainage." ¿major complications occurred in only one patient, in the control group.The patient developed severe hemobilia with gastrointestinal bleeding and underwent superselective hepatic artery embolization 1 day later to treat a pseudoaneurysm caused by the puncture.¿ medwatch report identified by patient identifier (b)(6) captures the neff percutaneous access set (this report).Medwatch report identified by patient identifier (b)(6) captures the 22-g chiba needle.Per the article, no other adverse effects were reported for this incident.
|
| |
|
Additional Manufacturer Narrative
|
|
The previously submitted description of event referenced an additional report (medwatch report #:1820334-2020-00746) to capture the chiba needle.Based on review of sales history for neff percutaneous access sets, it is likely that the chiba needle referenced by that report was a component of a neff percutaneous access set rather than an independent device sold separately.Because it is now believed that this needle is a component of the set addressed by this report, the investigation of both the chiba needle and other components of the neff percutaneous access set will be included in this report.Investigation ¿ evaluation.It was reported to cook that a neff percutaneous access set (npas) was described in a journal article from 2018, in which the patient developed severe haemobilia with gastrointestinal bleeding related to a npas device.The patient underwent hepatic artery embolization one day later.Attempts to acquire additional information from the user facility were executed, however no additional information was provided to cook in response to this incident.A review of the complaint history and quality control were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Therefore there was no visual inspection of the complaint device.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of product labeling could not be conducted because neff percutaneous access sets are not supplied with an instructions for use (ifu).The device history record (dhr) could not be reviewed due to the lack of rpn and lot number information from the user facility.A complaints database search could also not be completed due to the lack of information reported by the user.A sales shipment search was completed but a specific lot(s) could not be determined.As related non-conformances could not be determined, and adequate inspection activities have been established, it was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, no returned product for evaluation, and results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
| |
|
Additional Manufacturer Narrative
|
|
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
| |
|
Event or Problem Description
|
|
Correction regarding patient identifiers of related reports: medwatch report identified by patient identifier (b)(6) captures the neff percutaneous access set (this report).Medwatch report identified by patient identifier (b)(6) captures the 22-g chiba needle.
|
| |
|
Search Alerts/Recalls
|
|
|
