MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problems Kinked (1339); Device-Device Incompatibility (2919)

Patient Problem Death (1802)

Event Date 10/10/2016

Event Type  Death  

Manufacturer Narrative

(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: ¿the complainant reported that in 2016, a male was being treated for an acute myocardial infarction and cardiogenic shock.The patient was brought to the cardiac cathlab for care and an impella cp was prepped in the usual fashion.Upon insertion into the cook 14fr x 30 cm introducer sheath, there was an inability to pass the cp through the sheath and into position for support.Due to the need for support, a second cook sheath was then inserted.Once again there was difficulty inserting the cp.Two attempts were made to position, and during these attempts the cook sheath was observed to be kinked.The physician pulled back upon the impella cp to remove it, and with the exerted force, did fracture the impella cp into two distinct pieces.The portion of the cp with the inlet cage and pigtail remained lodged within the cook sheath.At this time due to the intraprocedural instability, the physician attempted to access the contralateral leg with a new sheath and place a new impella cp.The patient was unstable during this time with runs of ventricular tachycardia (vt) and ventricular fibrillation (vf).The patient expired during this time due to cardiac instability.The patient had lost all rhythm and was exhibiting pulseless electrical activity (pea).The team did relay to the representative that had the patient survived, the team would have utilized a snare to retrieve the portion of the impella cp lodged within the kinked cook sheath.Due to the patient's demise, the portion was not retrieved for analysis'.¿ this report was created to capture the 2nd cook sheath mw#1820334-2017-03633.Please see mw#1820334-2017-03681 for the first sheath.A request was made to abiomed to return the sheath.The device has not be returned.

Manufacturer Narrative

Investigation - evaluation: a review of the drawings, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned to aid the investigation.As the lot number for the complaint device is unknown, a representative device could not be obtained.No images/videos of the failure were provided.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.Per the maude report ¿the patient was being treated for acute myocardial infarction and cardiogenic shock¿ and had ¿runs of ventricular tachycardia and ventricular fibrillation.¿ these conditions cause vasoconstriction and could impact placement of the sheath.Per the impella ifu, ¿never advance the guidewire or sheath when resistance is met.Determine the cause of resistance using fluoroscopy and take remedial action.Note: use of the cook introducer may require higher than expected insertion and removal forces." based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined; however it is likely that the impella device was unable to pass through the sheath as a result of the sheath kinking.It is possible that the sheath kinking occurred due to user technique and/or patient anatomy.The delay in treatment encountered, and difficulty placing the impella device could have contributed to the patient's clinical decline as part of a number of factors.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6997011
• MDR Text Key: 90902530
• Report Number: 1820334-2017-03633
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPELLA CP
• Patient Outcome(s): Death