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

Model Number	G53008
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = lead tech.Device evaluated by mfg, device evaluation has begun; however, a conclusion is not yet available.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
As reported, during a procedure involving removal of a cook celect inferior vena cava filter, an unknown long string was noted to be hanging from a cloversnare 4-loop vascular retriever's sheath, after the snare and filter were pulled from the sheath.The procedure had been successfully completed when the event occurred.Fluoroscopy was used to look for additional pieces within the patient; however, nothing was found.A section of the device did not remain inside the patient¿s body.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.
Event or Problem Description
Additional information was received 20sep2022.The filter had been implanted for seven months and seemed to collapse fine.Reportedly, the user could not tell if the string came from the inner or outer sheath; however, upon initial evaluation of the device on 13sep2022, the string was noted at the distal tip of the inner sheath.
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.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving removal of a cook celect inferior vena cava filter, an unknown long string was noted to be hanging from a cloversnare 4-loop vascular retriever's sheath, after the snare and filter were pulled from the sheath.The procedure had been successfully completed when the event occurred.Fluoroscopy was used to look for additional pieces within the patient; however, nothing was found.A section of the device did not remain inside the patient¿s body.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 20sep2022.The filter had been implanted for seven months and seemed to collapse fine.Reportedly, the user could not tell if the string came from the inner or outer sheath; however, upon initial evaluation of the device on 13sep2022, the string was noted at the distal tip of the inner sheath.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the returned complaint device was also conducted.The inner sheath of the cloversnare 4-loop vascular retriever set was returned to cook for investigation.A string was noted at the distal tip of the inner sheath, and part of the inner portion of the tubing/sheath material was sticking out.Needle nosed tweezers were used to detach the string, which was determined to be part of the sheath.Cook completed a review of the device history record (dhr).The dhr for the complaint lot recorded no relevant non-conformances.A search of complaint history found no additional lot related complaints.The component lot for the inner sheath recorded one relevant non-conformance on 10 devices, however, all non-conforming product was scrapped.This subassembly was used on 13 other final lots, and a search of complaint history on these lots found no additional related complaints.Although the noted non-conformance is relevant to the reported failure mode, all non-conforming product was scrapped, there are 100% inspections to capture this non-conformance, adequate inspection activities have been established, and no other lot related complaints have been received from the field.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 15427780
• Report Number: 1820334-2022-01482
• Device Sequence Number: 7522614
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)250608(10)14776152
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K112185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2025
• Device Model Number: G53008
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: 14776152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 12/09/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/04/2022; 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Female