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

Model Number G51835

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k): k160593.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the doctor was using an indy otw vascular retriever with exceptional force and it eventually broke.As reported, the doctor was attempting to retrieve a covered balloon expandable stent that had come off its balloon.The physician was not doing this over a wire.At the time, the doctor was advised this was off label use of the device.It was obvious that the stent the doctor was attempting to retrieve was jammed/stuck in the patient somehow.He was applying significant force and began to pull the inner segment of the snare out through the outer sheath.The doctor was advised that the snare and sheath are supposed to be removed together and with less force applied.Upon removal of the snare it was found that the wire loops of the snare were still inside the patient.The wires loops were later retrieved with alligator forceps.There was no unintended section of the device remaining inside the patient¿s body.The patient did not require any additional procedures and did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation/evaluation: the indy otw vascular retriever was not returned for investigation.Without the complaint device, a physical investigation was not able to be completed.A review of the device history record, complaint history, the instructions for use and quality control data was conducted.A review of the device history record showed no non-conformances were identified.A review of complaint history revealed this is the only complaint associated with lot number 8552387.The instructions for use (ifu) provided with the device instructs the user to insert the retriever over-the-wire through an in situ guiding catheter or introducer sheath and advance it to the desired position.It was reported that the doctor did not advance the snare over a wire as indicated in the instructions for use.There is no evidence to suggest that not following this step would have contributed to this event.After the foreign body is caught within the snare, the ifu then instructs to tighten tuohy-borst to maintain tension on the catheter controlling the foreign body, withdraw the retriever to a peripheral location and retrieve the foreign body.It is clear from the reported information that the doctor was trying to pull the snare and stent through the sheath of the snare.The ifu indicates that the tuohy-borst should be tightened.If tightened, the inner catheter and snare would have been locked in place with the outer sheath to hold the foreign body in place while retracting the device.The doctor did not follow this step of the ifu and instead tried to pull the snared stent through the sheath.The snared stent was likely too big to pass through the sheath, resulting in the separation of the snare from the inner catheter with enough force applied from the doctor.There is no evidence that the device was manufactured out of specifications.The device was not returned for analysis.The return of the device would provide more definitive evidence on how exactly the snare broke and what caused it.With the information available, the cause of this complaint is product use or handling related - did not follow instructions/label.The physician did not follow the steps listed in the ifu provided with the device despite instructions and warnings from the cook representative present during the procedure.The force the doctor was using with the device, likely exceeded the tensile strength on the inner catheter of the device resulting in the deformation and eventually breaking of the inner catheter at a point distal of the snare.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

Event Description

No additional information reported since the initial report was submitted.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7603359
• MDR Text Key: 111136356
• Report Number: 1820334-2018-01864
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 00827002518353
• UDI-Public: (01)00827002518353(17)210131(10)8552387
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: G51835
• Device Catalogue Number: INDY-8.0-35-55-40
• Device Lot Number: 8552387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR