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	12/08/2020
Type of Reportable Event	Malfunction
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 celect filter retrieval a cloversnare 4-loop vascular retriever was in use when one of the snare loops broke in half.The broken loop was still attached to the snare.The snare and snare catheter were then removed and another same device was used to remove the filter.No portion of the device was left inside the patient.This did not result in any additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, during a celect filter retrieval a cloversnare 4-loop vascular retriever was in use when one of the snare loops broke in half.The broken loop was still attached to the snare.The snare and snare catheter were then removed and another same device was used to remove the filter.No portion of the device was left inside the patient.This did not result in any additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: a visual inspection and of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, drawing, specifications, the instructions for use, manufacturing instructions, and quality control data.The complainant returned the complaint device to cook for investigation.Physical examination of the returned device found the snare loop to be broken.No other visible damage was observed.At this time, cook concluded that the device was manufactured within specification.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: "excessive force should not be used to manipulate or retrieve foreign objects." cook has concluded a component failure contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 new patient or event information 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
• MDR Report Key: 11026800
• Report Number: 1820334-2020-02323
• Device Sequence Number: 18989987
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)231108(10)13539968
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 11/08/2023
• Device Model Number: G53008
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: 13539968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1