MAUDE Adverse Event Report: COOK INC INDY OTW VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Model Number N/A

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Address postal code: (b)(6).Initial reporter occupation: vascular surgeon.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 Description

It was reported that during a procedure that a wire guide (300 cm) became caught in the cook indy otw vascular retriever and was unable to be released.The wire had to be cut to release from cook indy otw vascular retriever.The patient's anatomy was not overly tortuous.The device was returned to the manufacturer for investigation on (b)(6) 2022.During the review of the device it was discovered that the catheter shaft had separated from the hub.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: h6 - annex a.Correction: h6 - annex g.Investigation ¿ evaluation: (b)(6) hospital informed cook on (b)(6) 2022 of an event involving an indy otw vascular retriever (rpn: (b)(6), lot: unknown).The 300 cm glide wire caught in the snare and was unable to be released.The physician had to cut the glide wire to release it from the device.It was reported that the patient¿s anatomy was not overly tortuous.No unintended part of the device remained inside the patient¿s body.There were no additional procedures required and no adverse effects were reported to the patient due to this occurrence.Reviews of the documentation, including the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.One used device was returned to cook for evaluation.The sheath¿s flare was out of the hub.When the sheath was held close to the hub, the snare would come out of the sheath and then could be drawn back in.It was noted that the snare could not be released from the hub; however, if the sheath was held close to the hub, the snare could be released.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that appropriate inspections are in place relative to the reported device failure.A review of the device history record (dhr) could not be conducted due to the lack of lot information from the customer.Cook also reviewed product labeling.The device was packaged with ifu t_indyotw_rev5.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.Precautions: manipulation of the product requires fluoroscopic control.Visually inspect the product before use to ensure it is undamaged.Instructions for use: 4.Insert the retriever over-the-wire through an in situ guiding catheter or introducer sheath and advance it to the desired position.5.While holding the flexor sheath in position, loosen tuohy-borst and advance the inner catheter through the flexor sheath until the snare emerges from the distal tip.Note: the snare will expand upon emergence from the flexor sheath.6.Position the retriever so that the foreign body, such as a wire guide or catheter, is caught within the snare.While maintaining the snare position, slide the flexor sheath forward to capture the foreign body.7.Tighten tuohy-borst to maintain tension on the catheter controlling the foreign body, withdraw the retriever, including the snare and flexor sheath assembly, to a peripheral location and retrieve the foreign body.After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Evidence provided by the complaint facility, device failure analysis, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure contributed to the cause of the reported event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: INDY OTW VASCULAR RETRIEVER
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15095942
• MDR Text Key: 304632088
• Report Number: 1820334-2022-01272
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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: INDY-8.0-35-55-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 12 FR ANL1.; COOK ILIAC BRANCH DEVICE, ZBIS-12-45-41.; GLIDE WIRE, THRU AND THRU, 300 CM.
• Patient Sex: Male