MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. CATERPILLAR EMBOLIZATION SYSTEM; ARTERIAL EMBOLIZATION DEVICE

Catalog Number CTP027015U

Device Problems Collapse (1099); Difficult to Remove (1528); Unintended Movement (3026)

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

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (10/2021).

Event Description

It was reported that during placement of an arterial embolization device, the device allegedly was difficult to advance.It was further reported that the device allegedly had buckling of the wire outside of the micro catheter.Reportedly the entire device flipped out of the vessel.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review:the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Per the complaint history review (chr), this is the first complaint reported for this product/lot number combination.Investigation summary: the sample was not returned for evaluation.The result of the investigation is inconclusive for the reported difficult to remove, unintended movement and collapse issues.The root cause for the reported difficult to remove, unintended movement and collapse issues could not be determined based upon the available information received from the field communications.Labeling review: the instructions for use for the caterpillar arterial embolization system was reviewed and contains the following information relevant to the reported event: precautions: check that the device has not been damaged prior to use.Do not use if any damage is visible or if any part of the implant is outside of the loader.If loader or wire kinks or becomes damaged during preparation, do not use the device.Do not advance the implant outside of the loader prior to insertion into the delivery catheter.Verify that the delivery catheter that is used is compatible with the caterpillar¿ and caterpillar¿ micro arterial embolization devices prior to use if excessive resistance beyond what would be expected is encountered at any point during advancement of the caterpillar¿ and caterpillar¿ micro arterial embolization devices through the delivery catheter, stop and remove the device and delivery catheter as one unit/together.Do not advance or retract the caterpillar¿ and caterpillar¿ micro arterial embolization devices from the loader without attaching the loader via the tuohy borst to the delivery catheter hub.Do not twist or rotate the delivery wire during advancement, because the implant may detach prematurely.D4(expiry date: 10/2021).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Event Description

It was reported that during placement of an arterial embolization device, the device allegedly had difficulty to advance.It was further reported that the device allegedly had buckling of the wire outside of the micro catheter.Reportedly the entire device flipped out of the vessel.There was no reported patient injury.

• Brand Name: CATERPILLAR EMBOLIZATION SYSTEM
• Type of Device: ARTERIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 10687489
• MDR Text Key: 211654368
• Report Number: 9616666-2020-20005
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• PMA/PMN Number: K191532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CTP027015U
• Device Lot Number: CMDY0557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other