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

Model Number	G53008
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during retrieval of a cook celect platinum inferior vena cava (ivc) filter, which had been in place for approximately eleven months, a cloversnare 4-loop vascular retriever's catheter was unable to detach the filter feet from the caval wall.The filter feet were reportedly "securely planted".The snare captured the filter hook and the catheter was then advanced over the filter, covering the entire filter with exception of the feet; however, the filter feet would not detach from the wall of the ivc.The user pulled hard enough that the filter hook straightened.The retrieval device was removed from the patient.The "catheters" were reportedly accordioned.One of the legs of the filter then detached from the caval wall and crossed over another leg.The patient was immediately transferred to another facility to complete the filter retrieval procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation = manager.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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during retrieval of a cook celect platinum inferior vena cava (ivc) filter, which had been in place for approximately eleven months, a cloversnare 4-loop vascular retriever's catheter was unable to detach the filter feet from the caval wall.The filter feet were reportedly "securely planted".The snare captured the filter hook and the catheter was then advanced over the filter, covering the entire filter with exception of the feet; however, the filter feet would not detach from the wall of the ivc.The user pulled hard enough that the filter hook straightened.The retrieval device was removed from the patient.The "catheters" were reportedly accordioned.One of the legs of the filter then detached from the caval wall and crossed over another leg.The patient was immediately transferred to another facility to complete the filter retrieval procedure.Corrected information: h6 (annex g).Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.There was no visible damage noted to the clover snare or the catheter.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.Cook also reviewed the product labeling, including the instructions for use (ifu).It warns the user ¿excessive force should not be used to manipulate or retrieve foreign objects.¿ the information provided upon review of the returned device evaluation, complaint file, dmr, dhr, and ifu provides evidence that the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information and results of the investigation, cook has concluded that procedural issues contributed to this failure mode.The user stated that the filter was completely embedded into the cava wall and that they used a force strong enough to straighten the hook on the filter.The ifu for the complaint device cautions that excessive force should not be used to manipulate or retrieve foreign objects.The risk analysis for this failure mode 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 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: 16817761
• Report Number: 1820334-2023-00514
• Device Sequence Number: 7124988
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)260116(10)15167120
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2026
• Device Model Number: G53008
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: 15167120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 33 YR
• Patient Sex: Female