MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombosis (2100)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant products: impella cp, 14 fr oscor introducer, intra-aortic balloon pump, 10 fr, 12 fr and 14fr dilators.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

During a data pull for trending the following was discovered on the maude database: "a male suffered cardiac arrest while playing hockey, had an aed placed and cpr was performed.The patient underwent a pci of his left anterior descending artery, and an iabp was placed.The patient continued to decompensate, requiring an escalation of inotropes and vasopressors; and was experiencing intermittent episodes of vtach.The patient was brought to the cardiac cath lab with the plan to remove the iabp and place an impella cp.The iabp was removed and the vessel was dilated with 10 fr, 12 fr and 14fr dilators.The 14fr oscor sheath was unable to advance smoothly into the vessel, therefore the 14 fr oscor introducer was exchanged for a 14 fr long cook sheath.The impella cp was inserted and flow was initiated.The physician performed a peripheral angiogram to assess distal limb flow.The patient was reported to be hypotensive, with unstable pulsatility, and required blood products during support.Upon admittance to icu in the evening the pump was repositioned using tte.The patient was transferred to a new facility later in the evening.According to the abiomed field representative the patient's antigoagulation was subtherapeutic at times.The patient was administered integrilin, in addition to heparin in the impella purge solution.The patient arrested and was placed on ecmo; and the impella performance level was decreased to p-level 2.The patient developed a hematoma at the ecmo, left groin insertion site and the impella insertion site was reported to have oozing that resolved.The patient stabilized over the next several days, and was taken off ecmo.The patient remained on impella support for several more hours after which the impella was removed through a 14 fr cook sheath.Upon removal, there was visualization of thrombus on the pigtail.A thrombus was reported to obstruct flow to the extremity, until an embolectomy was performed; at which point flow was returned.The clinical team stated the impella saved the patient's life.There was no indication of any further adverse effect to the patient following the embolectomy".The device is not being returned.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation a review of the complaint history, documentation, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.No photographs of the failure were provided.The device lot number is unknown.Thus, a review of the device history record, nonconformance history, and related product complaints query could not be conducted.There is a possibility that the thrombus was developed inside the sheath, considering the fact that the sheath was left inside the patients anatomy for 6 days whereas sheaths are designed to be used during endovascular procedure and not be left indwelling.The patient's anticoagulation was subtherapeutic and also it is not clear if the sheath was properly flushed during the six day time period as instructed in the ifu.However, based on the available information and without the benefit of a returned complaint device, a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6995335
• MDR Text Key: 90844338
• Report Number: 1820334-2017-03630
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention