MAUDE Adverse Event Report: COOK INC CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	G53008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
As reported, during a filter retrieval procedure in which a cloversnare 4-loop vascular retriever was used, another manufacturer's wire guide separated and remains in the patient.The other manufacturer's filter was placed in (b)(6) 2021.During the retrieval procedure, the physician was attempting a wire loop-snare technique through an unspecified cook 16 french, 45-centimeter sheath.The other manufacturer's 0.035-inch, 260-centimeter wire was snared, and while pulling the device through the sheath, the wire separated.The separated segment of the wire was noted on imaging.The procedure was stopped due to the length of the procedure, as the patient had received 6 mgy of radiation.The filter was not retrieved.Reportedly, the physician felt that the wire fragment would not mobilize; therefore, it was left in the patient.The physician performing the procedure will consult with the referring physician.There has been no alleged malfunction of any cook device.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
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 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.
Event or Problem Description
Additional information was received 25jul2022.Excessive force was used while pulling on the wire and snare.All components of the complaint device were used; however, per the customer, the complaint device did not cause or contribute to separation of the other manufacturer's wire, as the physician had switched to another manufacturer's snare when the wire snapped.
Additional Manufacturer Narrative
Summary of event: as reported, during a filter retrieval procedure in which a cloversnare 4-loop vascular retriever was used, another manufacturer's wire guide separated and remains in the patient.The other manufacturer's filter was placed in november of 2021.During the retrieval procedure, the physician was attempting a wire loop-snare technique through an unspecified cook 16 french, 45-centimeter sheath.The other manufacturer's 0.035-inch, 260-centimeter wire was snared, and while pulling the device through the sheath, the wire separated.The separated segment of the wire was noted on imaging.The procedure was stopped due to the length of the procedure, as the patient had received 6 mgy of radiation.The filter was not retrieved.Reportedly, the physician felt that the wire fragment would not mobilize; therefore, it was left in the patient.The physician performing the procedure will consult with the referring physician.There has been no alleged malfunction of any cook device.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was received 25jul2022.Excessive force was used while pulling on the wire and snare.All components of the complaint device were used; however, per the customer, the complaint device did not cause or contribute to separation of the other manufacturer's wire, as the physician had switched to another manufacturer's snare when the wire snapped.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation; however, a photo was provided, showing the portion of the competitor¿s wire left in the patient.Per the reporter, there was no malfunction of the cook device.A document-based investigation evaluation was performed.No non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu cautions that excessive force should not be used to manipulate or retrieve foreign objects.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that unintended user error contributed to this event.There has been no evidence that the cook device malfunctioned.Per the customer, excessive force was used during the filter retrieval.The ifu for the complaint device warns against use of excessive force during manipulation or retrieval of foreign objects.The risk analysis was reviewed, and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.
Event or Problem Description
No additional information has been received since the last report was submitted.

• Brand Name: CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER
• Common Device Name: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15074103
• Report Number: 1820334-2022-01246
• Device Sequence Number: 12090739
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)240506(10)13944955
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K112185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2024
• Device Model Number: G53008
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: 13944955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 10/13/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/22/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK 16FR X 45CM SHEATH; CORDIS OPTEASE FILTER; ENSNARE; MEDTRONIC 0.035, 260 CM WHOOLY WIRE; RCFW-16.0P-38-45-RB
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male