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

Model Number G51835

Device Problem Break (1069)

Patient Problems Blood Loss (2597); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

The pma/510(k): k160593.(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

It was reported the male patient underwent an endovascular aneurysm repair (evar) procedure with an internal branched device (ibd).As reported, while snaring the wire through the pre-loaded catheter from the ibd the indy otw vascular retriever was difficult to remove and broke in the patient.There was no visible reason for the difficult removal.The catheter was removed but they had to retrieve the snare loop in the external iliac by a crossover procedure with an additional indy snare and the use of a single loop goose neck snare kit.The external iliac was stented with a self-expandable uncovered stent and the snare was retrieved successfully.The initial reporter stated "there was a lot of blood loss and it was a very long operation." the patient has been released from the hospital.

Event Description

There has been no new information received since the last report was submitted.

Manufacturer Narrative

Conclusions code: cause not established (4315).Investigation: evaluation: a visual inspection and dimensional verification of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, instructions for use, and quality control data.The device was returned used and in two pieces consisting of the sheath with inner catheter and the broken snare that separated distal to the suture wraps.The snare was broken just distal to the suture wrap and appeared pulled due to excess force applied.The inner catheter distal of the snare was stretched and broken.There was a kink on the sheath approximately 7 cm from the proximal end of the connector cap.It could not be determined if this was a result of the procedure or from shipping and handling to the return of the device.There was also a kink on the inner catheter 58.5 cm from the proximal end of the connector cap.This appeared to be misshapen due to excessive force applied.There were multiple kinks evident on the separated inner catheter shaft proximal of the snare.The suture wraps on the separated component containing the proximal inner catheter and snare have unraveled and is tangled in the snare.The proximal tip of the flexor sheath appeared deformed and out of round.The outer diameter of the inner catheter measured out of specification at the point of separation and was likely a result of forced separation of the inner catheter.The length of the suture wraps also measured out of specification.The decreased length was a result of the unraveling of the suture wraps observed within the snare.The outer diameter of the snare measured to be within specification.The device was sent to the supplier and a supplier evaluation was completed.The results of their evaluation concluded that a tube tear was identified just below the wire adhesion area.Stretch marks were found on the tube around the torn area.No disconnection of the wire to the shaft was observed.The product was found to be within specifications.The complaint product lot was tested and released as per the required process.There was no non-conforming product identified in house or in the field based on their investigation.The root cause could not be identified.The device history record was reviewed and no non-conformances were noted.A search of complaint records revealed this is the only complaint associated with complaint lot number: 8448951.The instructions for use (ifu) provided with the device states to, "position the retriever so that the foreign body is caught within the snare.While maintaining the snare position, slide the flexor sheath forward to capture the foreign body.Tighten the tuohy-borst to maintain tension on the catheter controlling the foreign body, withdraw the retriever to a peripheral location and retrieve the foreign body." the condition of the returned device suggests that the inner catheter and sheath may not have been pulled out together.Deformation on the tip of the flexor sheath and stretching of the inner catheter was indicative of force applied while retracting the snare and ibd wire guide.If the snare and sheath were retracted together as instructed in the ifu, then this event could have been a result of immobility of the ibd wire guide.If the wire guide was stuck within the branch device sheath, then the snare and sheath could not have been pulled out.Excessive force applied during removal could result in the stretching and separation of the inner catheter.Evidence provided suggests that this was not the case because there were no further difficulties reported in snaring the ibd wire guide.The ifu advises, "the outer diameter of the device's flexor sheath is 8 french (2.63 mm) nominal.Always check fit through the intended guiding catheter or introducer sheath prior to use." using a guiding catheter or introducer sheath that is too narrow could result in difficulties introducing and removing the snare.With the information reported for this complaint, there is no evidence that this contributed to the event but it cannot be ruled out as a possible cause.This complaint is confirmed based on the returned device.Evaluation of the returned device gave no indication that it was manufactured out of specifications.The origin of the resistance felt during retraction of the snare was most likely a result of withdrawing the snare through the sheath or from the wire guide being stuck in the ibd sheath.The condition of the returned device indicated that excessive force was likely used during retraction, ultimately resulting in the stretching and separation of the inner catheter and snare.Because improper use or excessive force cannot be confirmed from the information provided, a definitive cause could not be established.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor 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: INDY OTW VASCULAR RETRIEVER
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7472243
• MDR Text Key: 106864582
• Report Number: 1820334-2018-01042
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 00827002518353
• UDI-Public: (01)00827002518353(17)201215(10)8448951
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G51835
• Device Catalogue Number: INDY-8.0-35-55-40
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/19/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention