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 Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

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 sheath was the cause of the lure 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 complaint history, device history record, instructions for use (ifu), trends, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.A leak test was performed on the outer sheath by occluding the tubing with hemostats, threading a luer lock syringe filled with air to the proximal luer fitting, and submerging the device in water.When injecting air, leakage/air bubbles were detected at the joint between the syringe and outer sheath proximal fitting.When attempting to further tighten the syringe onto the proximal fitting, the threads slipped and the syringe continued to rotate.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.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: 6016609
• MDR Text Key: 57008514
• Report Number: 1820334-2016-01101
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)190725(10)7146998
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1