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

Model Number G53008

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

Occupation = non-healthcare professional- lab manager.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a filter retrieval procedure via right internal jugular access, a cloversnare4-loop vascular retriever wire separated from the torque device.The (b)(6) male patient had a history of pulmonary embolism with a cook tulip filter in place since (b)(6) 2018.He was reported t o be slightly above average weight, and the patient's anatomy was described as "typical".Per the customer, the wire "popped off" of the torque device very easily, with the snare wire then entering into the snare catheter.The user cut the catheter and used a hemostat to retrieve the wire and advance the sheath over the filter completely.The procedure was prolonged by approximately twenty minutes and "everything was removed as intended".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.

Event Description

No additional patient or event information has been received since the last report was submitted on 16jul2019.

Manufacturer Narrative

Additional information: d10.Investigation ¿ evaluation.A visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned device noted the snare catheter was advanced through the proximal end.The pin vise was separated from the snare wire.There was extensive biological matter throughout he device.The snare catheter tubing was cut 11.1 cm, and there was a hemostat mark at 12.5 cm.The exposed length of the snare wire and the pin vise were undamaged.The pin vise could be re-fastened securely onto the wire, and does not detach when forcefully pulled.The snare wire outer diameter measured within specification.The connecting cap inner diameter measured within specification.No other damage was noted.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other complaint associated with the complaint device lot.However, the complaint is unrelated to the reported failure mode.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: excessive force should not be used to manipulate or retrieve foreign objects.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook confirmed this complaint as "fitting separated" based on customer testimony and device evaluation.According to the customer, the patient had typical anatomy.The cook tulip filter was implanted (b)(6) 2018 and the event occurred (b)(6) 2019.The gunther tulip filter is intended for short term use, less than 6 months.In this case, it appears that the filter was in place approximately 9 months.It is unknown if the filter was embedded into the caval wall or if excessive force was applied to the device.The ifu warns against the use of excessive force when manipulating or retrieving foreign objects.Cook confirmed that the device was manufactured within specification.Cook cannot establish a definitive cause for this event with the available information.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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.

• 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
• MDR Report Key: 8796738
• MDR Text Key: 151286861
• Report Number: 1820334-2019-01712
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)220509(10)9728931
• Combination Product (y/n): N
• PMA/PMN Number: K112185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: G53008
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: 9728931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR