MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Catalog Number RCFW-12.0-38-45-RB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device will be returned.Pma/510(k) number = k171999.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported to cook by another manufacturer, a cook performer introducer was used during a procedure to place the other manufacturer¿s heart failure monitoring implant device.During the procedure, the patient developed cardiac tamponade, requiring resuscitation and surgical intervention.There has been no alleged malfunction of the cook performer introducer.Reportedly, prior to the procedure, the patient complained of back pain, difficulty breathing, and leg pain.Pain medication was administered, and the physician consulted a fellow prior to proceeding with the procedure.Access was obtained in the right femoral vein using ultrasound guidance and an unknown 12 french sheath was placed.An unspecified 7 french balloon wedge pressure catheter was advanced through the sheath to begin the right heart catheterization.During the procedure, the user observed that the patient had a large right atrium, which was also confirmed on x-ray.The large right atrium allowed the balloon wedge pressure catheter to prolapse on itself, making it difficult to further advance the catheter through the right atrium, right ventricle, and pulmonary artery.When the catheter was guided into the left branch of the pulmonary artery, a pulmonary angiogram was performed to identify the implant site for the other manufacturer¿s pulmonary artery pressure/ heart failure monitoring sensor.Once the implant site was identified, an unknown glidewire was removed and a 0.018-inch, 300-centimeter wire was advanced.Several attempts were made to guide the 0.018-inch wire into the selected branch of the left pulmonary artery; however, advancement was difficult as the anatomy was reportedly not easily attainable, and the catheter kept prolapsing.The wire was placed in the selected location and the catheter was removed.The other manufacturer¿s implant device was then inserted over the wire guide and was guided to the left branch of the pulmonary artery; however, the device would not advance far enough into the vessel to reach the selected implant site.The implant device was removed, as well as all catheters and wire guides.The cook performer 12 french, 45-centimeter sheath was then placed in the right femoral access site.Reportedly, the tip of the 45-centimeter sheath was advanced to the pulmonary artery.A catheter was advanced through the sheath into the right atrium, right ventricle, and right pulmonary artery.A pulmonary angiogram was performed to determine if the sensor could be implanted on that side.Reportedly, at some point after the performer introducer was inserted, the patient began to complain verbally, and the patient¿s status declined.The implant procedure was stopped and the patient lost consciousness.Resuscitation was initiated, as the patient¿s pulse was reportedly faint/lost and the blood pressure was reportedly low/lost.Emergency personnel were consulted, including anesthesia, a cardiovascular surgeon, interventional cardiologist, and an electrophysiologist.A tracheoesophageal echocardiogram was performed, finding a likely perforation on the right side of the heart (right atrium, right ventricle, pulmonary artery) leading to a pericardial effusion and cardiac tamponade.The pericardial effusion was drained.In addition to drainage of the pericardial effusion, resuscitative measures included chest compressions, transfusion of blood, and administration of various medications, including epinephrine.The patient was revived, with return of pulse and blood pressure.The patient was moved to the operating room for further assessment and intervention.Further complications were reported after surgical intervention for the cardiac perforation, leading to multi-system organ failure.There has been no report of any malfunction or failure of the cook performer introducer.Per the physician, the patient lifted her leg during the procedure and the physician believes that the sheath was pulled back when the leg was lifted, causing the injury.No part of the device remained in the patient.

Event Description

Additional information was received from the customer 22feb2021.Per the customer, the patient incident did not involve any cook device.

Manufacturer Narrative

Summary of event: as reported to cook by another manufacturer, a cook performer introducer was used during a procedure to place the other manufacturer¿s heart failure monitoring implant device.During the procedure, the patient developed cardiac tamponade, requiring resuscitation and surgical intervention.There has been no alleged malfunction of the cook performer introducer.Reportedly, prior to the procedure, the patient complained of back pain, difficulty breathing, and leg pain.Pain medication was administered, and the physician consulted a fellow prior to proceeding with the procedure.Access was obtained in the right femoral vein using ultrasound guidance and an unknown 12 french sheath was placed.An unspecified 7 french balloon wedge pressure catheter was advanced through the sheath to begin the right heart catheterization.During the procedure, the user observed that the patient had a large right atrium, which was also confirmed on x-ray.The large right atrium allowed the balloon wedge pressure catheter to prolapse on itself, making it difficult to further advance the catheter through the right atrium, right ventricle, and pulmonary artery.When the catheter was guided into the left branch of the pulmonary artery, a pulmonary angiogram was performed to identify the implant site for the other manufacturer¿s pulmonary artery pressure/ heart failure monitoring sensor.Once the implant site was identified, an unknown glidewire was removed and a 0.018-inch, 300-centimeter wire was advanced.Several attempts were made to guide the 0.018-inch wire into the selected branch of the left pulmonary artery; however, advancement was difficult as the anatomy was reportedly not easily attainable, and the catheter kept prolapsing.The wire was placed in the selected location and the catheter was removed.The other manufacturer¿s implant device was then inserted over the wire guide and was guided to the left branch of the pulmonary artery; however, the device would not advance far enough into the vessel to reach the selected implant site.The implant device was removed, as well as all catheters and wire guides.The cook performer 12 french, 45-centimeter sheath was then placed in the right femoral access site.Reportedly, the tip of the 45-centimeter sheath was advanced to the pulmonary artery.A catheter was advanced through the sheath into the right atrium, right ventricle, and right pulmonary artery.A pulmonary angiogram was performed to determine if the sensor could be implanted on that side.Reportedly, at some point after the performer introducer was inserted, the patient began to complain verbally, and the patient¿s status declined.The implant procedure was stopped and the patient lost consciousness.Resuscitation was initiated, as the patient¿s pulse was reportedly faint/lost and the blood pressure was reportedly low/lost.Emergency personnel were consulted, including anesthesia, a cardiovascular surgeon, interventional cardiologist, and an electrophysiologist.A tracheoesophageal echocardiogram was performed, finding a likely perforation on the right side of the heart (right atrium, right ventricle, pulmonary artery) leading to a pericardial effusion and cardiac tamponade.The pericardial effusion was drained.In addition to drainage of the pericardial effusion, resuscitative measures included chest compressions, transfusion of blood, and administration of various medications, including epinephrine.The patient was revived, with return of pulse and blood pressure.The patient was moved to the operating room for further assessment and intervention.Further complications were reported after surgical intervention for the cardiac perforation, leading to multi-system organ failure.There has been no report of any malfunction or failure of the cook performer introducer.Per the physician, the patient lifted her leg during the procedure and the physician believes that the sheath was pulled back when the leg was lifted, causing the injury.No part of the device remained in the patient.Additional information was received from the customer 22feb2021.Per the customer, the patient incident did not involve any cook device.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.As no malfunction of the performer was reported, no reference analysis is needed.A device master record (dmr) review was performed, and device quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide a lot number for investigation.A search for all lots sold to the reporting customer on the reported rpn in the past three years found 4 potential lots (ns8013926, ns8335485, ns8915706, and ns7805149).Cook then completed a review of the dhrs for the potential lots.The dhrs for the potential lots records no non-conformances.A database search for complaints on the potential lots found no complaints reported from the field.The performer introducer is packaged with instructions for use.The current ifu for this device, t_performer_rev0, states that the device is intended to introduce therapeutic or diagnostic devices into the vasculature.Contraindications include: ¿this device is not intended for coronary or neurovascular use.¿ the ifu cautions that the product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.The ifu cautions not to attempt to insert the device if resistance is felt.Potential adverse events listed in the ifu include bleeding and vessel perforation.From the information provided upon review of the dmr, potential dhrs, and ifu, cook concluded that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided and the results of the investigation, cook has concluded that no device malfunction occurred.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: PERFORMER INTRODUCER
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11263198
• MDR Text Key: 233084203
• Report Number: 1820334-2021-00228
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RCFW-12.0-38-45-RB
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT CARDIOMEMS IMPLANT
• Patient Outcome(s): Life Threatening; Required Intervention