MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; FCG KIT, NEEDLE, BIOPSY

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pancreatitis (4481)

Event Date 10/08/2012

Event Type  Injury  

Event Description

Madhoun 2012 "the diagnostic accuracy of 22 gauge and 25 gauge needles in endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions: a meta-analysis.This meta-analysis suggests 25 g needle systems are more sensitive than 22 g needles for diagnosing pancreatic malignancy.The literature search yielded 36 potentially pertinent manuscripts for inclusion.Sixteen of these manuscripts were excluded immediately after initial review, most commonly because they did not pertain to the evaluation of pancreatic masses.Of the remaining twenty manuscripts, ten met the inclusion criteria for this meta-analysis (o fig.1) [12-21).Two studies were subsequently excluded.One of these described the overall diagnostic accuracy, but reported insufficient data to allow calculation of specific operating characteristics (true positives, true negatives, false negatives and false positives) [19).The other study reported results for overall diagnostic accuracy among two groups (pancreatic and others vs.Submucosal lesions), so it was not possible to extract the data for pancreatic lesions alone [21 ].Therefore eight studies were included in the final analysis.Eight studies involving 1292 subjects met the defined inclusion criteria.Of the 1292 patients, 799 were in the 22g group and 565 were in the 25g group (both needles were used in 72 patients).Eight studies were included in the sensitivity analysis and seven studies were included in the specificity analysis as one study comprised only patients with pancreatic cancer [14).The between-study variability (i.E.Heterogeneity) beyond what could be expected by sampling error was low with an 1 2 of 0.0% for the pooled sensitivity of the 22 g needle and for the specificity of both needles.The 12 for the pooled sensitivity of the 25 g needle was 30%, which was not considered substantial heterogeneity as per the a priori definition.This systematic review and meta-analysis of eus-fna for solid pancreatic lesions included a large cohort of patients (n = 1292) and quantitatively summarizes the available evidence regarding the diagnostic performance of the two most commonly used needle gauges for eus-fna of solid pancreatic lesions.These results demonstrated that the 25 g needle has superior sensitivity to the 22 g needle in this clinical context.All studies used disposable 25 g and 22 g eus-fna needles which incidentally all came from the same manufacturer (echotip and echotip ultra, cook endoscopy, (b)(4)).Of the five studies that reported adverse events, three described no complications with either needle (12, 13,20], while one study reported a 2% (11/540) risk of pancreatitis using the 22g needle (15], and another reported two cases of pancreatitis (2%) but did not specify the needle type (18].¿another study reported 2 cases of pancreatitis (2%) but did not specify the needle type.¿.

Manufacturer Narrative

Possible 510 k #'s: k083330, k092359 and k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 05-apr-2022.

Manufacturer Narrative

Possible 510 k #'s - k083330, k092359, k142688.Device evaluation: the unknown devices of unknown lot numbers involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.The exact rpn cannot be confirmed but this file is capturing 25g or 22g echotip ultra ultrasound needle.This file was created from the journal article "madhoun - the diagnostic accuracy of 22-gauge and 25-gauge needles.Pdf¿.Lab evaluation n/a.Document review including ifu review: prior to distribution, all echo-1-22 and echo-25 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is unknown a review of manufacturing records could not be performed.As per the instructions for use, (ifu0101) which informs the user about the potential complications "those associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest" the notes section of the instructions for use, ifu0101 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Also, ¿intended use: this device is used to sample targeted submuscosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is no evidence to suggest that the customer did not follow the instructions for use.(ifu0101).Image review: n/a.Root cause review: a definitive root cause could not be determined from the available information.However there was no evidence of a failure reported associated with the actual devices.As per cer "potential adverse events after eus-fna include hemorrhage, perforation, infection, abdominal pain, and pancreatitis (when the target lesion is within the pancreas).As per clinical input "this pancreatitis might be caused by the usage of device, so it is not due to patient condition.I can confirm this device performed as intended and did not cause or contribute to a death or serious injury." summary: complaint is confirmed based on customer testimony.According to the initial reporter, 2 patients developed pancreatitis.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: UNKNOWN
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 13050821
• MDR Text Key: 288289878
• Report Number: 3001845648-2021-00885
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2012
• Event Location: Hospital
• Date Manufacturer Received: 11/25/2021
• 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 Sequence Number: 1