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

Model Number	G53008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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 retrieval of an unknown filter, one of the cloversnare 4-loop vascular retriever loops fractured.According to the initial reporter, the physician had the filter snared by the hook and began advancing the 10 french sheath over the filter to collapse it.At that point, one of the snare loops separated, causing the filter to become loose inside the sheath.The snare loop did not detach from the device completely.When the snare was removed, the physician cut the broken loop off and continued the procedure with the same snare, recapturing the filter and successfully retrieving it.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 Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.As reported, during retrieval of an unknown filter, one of the cloversnare 4-loop vascular retriever loops fractured.According to the initial reporter, the physician had the filter snared by the hook and began advancing the 10 french sheath over the filter to collapse it.At that point, one of the snare loops separated, causing the filter to become loose inside the sheath.The snare loop did not detach from the device completely.When the snare was removed, the physician cut the broken loop off and continued the procedure with the same snare, recapturing the filter and successfully retrieving it.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the one loop of clover snare was broken.Additionally, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.As there are adequate inspection activities have been established and non-conforming product has been identified and scrapped during the manufacturing process it was concluded that there is evidence to suggest all items in the lot in house or in the field are manufactured to specification.No gaps were discovered in the manufacturing instructions, specifications, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.An ifu is provided with this device, which states "excessive force should not be used to manipulate or retrieve foreign objects.".Based on the information provided and the examination of the returned product, the investigation conclusion could not establish a definitive cause.The ifu does warn that excessive force should not be used to retrieve the filter this could be a potential cause for the failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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
• MDR Report Key: 10120518
• Report Number: 1820334-2020-01069
• Device Sequence Number: 11224456
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)230320(10)13069469
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 03/20/2023
• Device Model Number: G53008
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: 13069469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1