MAUDE Adverse Event Report: COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number CST-10

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

Patient Problems Needle Stick/Puncture (2462); Gastrointestinal Hemorrhage (4476)

Event Date 10/06/2005

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

"kahaleh et al.2006 ¿endoscopic ultrasound drainage of pancreatic pseudocyst: a prospective comparison with conventional endoscopic drainage¿.Endoscopic management of pseudocysts by a conventional transenteric technique, i.E.Conventional transmural drainage (ctd), or by endoscopic ultrasound-guided drainage (eud), is well described.Our aim was to prospectively compare the short-term and long-term results of ctd and eud in the management of pseudocysts.A total of 99 consecutive patients underwent endoscopic management of pancreatic pseudocysts according to this predetermined treatment algorithm: patients with bulging lesions without obvious portal hypertension underwent ctd; all remaining patients underwent eud.46 patients (37 men) underwent eud and 53 patients (39 men) had ctd.All ctd cystoenterostomy fistulas were created using a 10-fr cystoenterostome (wilson-cook medical and endo-flex instrumente, voerde, germany) [15].Following access to the pseudocyst, one or two 10-fr double-pigtail endoprostheses were placed.Bleeding was defined as any hemorrhagic event occurring during or after the procedure that required any intervention or blood transfusion.One patient developed bleeding of the cystoenterostomy site that responded to balloon tamponade.This file was created to capture the bleeding of the cystoenterostomy site, as per clinical input received this would be related to cst-10 device.

Manufacturer Narrative

Device evaluation: the cst-10 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided a document based investigation was conducted.This file was created from the journal article."kahaleh ¿ endoscopic ultrasound drainage of pancreatic pseudocyst prior to distribution, all cst-10 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, ifu0005-11 which informs the user about the potential adverse events "potential complications associated with gi endoscopy include, but are not limited to: sepsis, perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, allergic reaction to nickel, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.¿ there is no evidence to suggest that the customer did not follow the instructions for use 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 device.As per the ifu potential complications include hemorrhage.Complaint is confirmed based on customer testimony.According to the initial reporter, one patient developed bleeding of the cystoenterostomy site that responded to balloon tamponade.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• 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: 10490863
• MDR Text Key: 211017367
• Report Number: 3001845648-2020-00550
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CST-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2020
• Event Location: Hospital
• Date Manufacturer Received: 08/07/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male