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

Catalog Number DT-6

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Please note, this pr was opened to address the off-label use of the duette for the treatment of endoscopic variceal ligation, pr (b)(4) (emdr 1037905-2021-00127) captures the severe bleeding as described below. Varices was suctioned and the band released, the band did not sit snug /flush on the mucosa and lifted/retracted and in the process transected the vein causing more severe bleeding and made the situation acutely worse. They switched to cook product g34036 dt-6 and was able to complete the procedure and hemostasis was achieved (b)(4). Also the loading catheter kinked at the blue hook making it difficult to withdraw through the scope and firing handle valve (b)(4). As per phone conversation with the rep, she confirmed that the kinked loading catheter was observed on g22553 mbl-6, lot w4381250 and not the replacement device. Pr321921 was initiated for this issue. On 03/11/2021 we received confirmation that the use of dt-6 was a continuation of the initial procedure and not a required additional procedure. On 03/15/21: the rep confirmed the dt-6 was used off label for evl. During an endoscopic variceal ligation (evl) procedure, the physician used a cook 6 shooter saeed multi-band ligator. Varices was suctioned and the band released, the band did not sit snug /flush on the mucosa and lifted/retracted and in the process transected the vein causing more severe bleeding and made the situation acutely worse. They switched to cook product g34036 dt-6 and was able to complete the procedure and hemostasis was achieved. On 03/11/2021 we received confirmation that the use of dt-6 was a continuation of the initial procedure and not a required additional procedure. On 03/15/21: the rep confirmed the dt-6 was used off label for evl. No unintended part of the device remained inside the patient's body. No additional procedure was required due to this occurrence. An adverse effect was reported due to this occurrence - bleeding severity increased. Did any piece of the device remain inside the patient¿s body? yes. Please describe the object and how it was retrieved (if applicable): the band. Did the patient require any additional procedures due to this occurrence? no. Did the product cause or contribute to the need for additional procedure(s)? no. Please specify additional procedure(s) and provide details: n/a. Did the complainant inform of any adverse effect(s) on the patient due to this occurrence? no. Did the complainant inform that the product caused or contributed to the adverse effect(s)? yes. Please specify adverse effect(s) and provide details: bleeding severity increased. The band remained inside the patient¿s body to pass naturally. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient experienced severe bleeding.

• 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; o'halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 11654593
• MDR Text Key: 245754515
• Report Number: 3001845648-2021-00303
• 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: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: DT-6
• 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: 02/21/2021
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2021
• 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