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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported that during an unknown procedure a physician complained that a sheath was aspirating air after the filter was retrieved and it was noted that the luer lock was stripped.It was the physician's concern that the sheath should not be aspirating air while in the circulatory system.The physician was not sure if the sheath was defective or if the sheath was the cause of the luer lock stripping.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the instructions for use (ifu), trends, drawings, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided and the results of our investigation, the root cause was determined to be design-related.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that during an unknown procedure, the physician complained that a sheath was aspirating air after the filter was retrieved and the luer lock was stripped.It was the physician¿s concern that the sheath should not be aspirating air while in the circulatory system and the physician was not sure if the sheath was defective or if the event was caused by the stripping of the luer lock on the sheath.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6017437
• MDR Text Key: 57082414
• Report Number: 1820334-2016-01102
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VRS-6.0-90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1