MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/13/2020

Event Type  Injury  

Event Description

Vosko et al 2020 (duette) ¿ ¿snare-tip soft coagulation is effective and efficient as a first-line modality for treating intraprocedural bleeding during barrett's mucosectomy.Flat irregular or nodular areas of barrett's neoplasia with prior biopsies demonstrating high grade dysplasia and/or intramucosal cancer were candidates for mbm.Antiplatelet and/or anticoagulation therapy was withheld prior to endoscopic resection.A standardized detailed evaluation was performed using a high definition diagnostic gastroscope (olympus, japan) under white-light and narrow-band imaging, by a study investigator or senior interventional fellow under supervision.If an area of concern was identified, its margins were carefully delineated and an endoscopic resection plan was formulated before the mbm duette apparatus (cook medical, indiana, usa) was attached.A fractionated cutting current (endocut q, effect 3, cut duration 1, cut interval 6; erbe, germany) was used for all resections.Multiband mucosectomy-related intraprocedural bleeding (ipb): ipb occurred in 63 mbm procedures.Ipb treated by stsc: (off label use) stsc (snare-tip soft coagulation) was performed with the snare provided as part of the duette apparatus.The snare tip was positioned 1 -2 mm beyond the end of the snare sheath and then gently applied to the bleeding point for 1 -3 seconds using soft coagulation.Application was repeated up to five times to achieve hemostasis.51 patients (81.0%) underwent stsc as first-line modality.Patient outcomes: hemostasis was achieved in 48 cases.Apparatus disassembly: following stsc, mbm apparatus disassembly was required in 3 cases to facilitate a rescue modality.Hemostasis was achieved in 48 cases.Apparatus disassembly: following stsc, mbm apparatus disassembly was required in three cases (5.9%) to facilitate a rescue modality.Overall disassembly occurred in 23.8 % of cases by itt analysis.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted once the investigation is concluded.

Manufacturer Narrative

The duette device of lot number unknown involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Related to: mdr ref# 3001845648-2022-00115 (pr# (b)(4)) vosko ¿ ¿intraprocedural bleeding¿.As the lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all duette devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use states the following: ¿this device is for endoscopic mucosal resection in the upper gi tract.¿.There is evidence to suggest the user did not follow the ifu.A definitive root cause can be attributed to off label use.When the device is used outside of its validated state it is not possible to definitively state how the device will perform.The use of the device for snare-tip soft coagulation (stsc).Is outside of the intended use set out in the ifu.The complaint is confirmed based on customer testimony.According to the initial reporter, according to the initial reporter, one patient did require a blood transfusion.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: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• 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: 13652563
• MDR Text Key: 286859187
• Report Number: 3001845648-2022-00111
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• 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: 07/13/2020
• Event Location: Hospital
• Date Manufacturer Received: 02/03/2022
• 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: 69 YR
• Patient Sex: Male