MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80237

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 05/03/2023

Event Type  Death  

Event Description

It was reported that the male patient sustained a catastrophic aortic injury during an interventional radiology procedure (an arteriogram) and ultimately died from complications of this injury.The interventional radiologist that performed the arteriogram reported that the atherectomy system used during the procedure was ¿found to have broken off in the patient.¿ the physician notes state that an abdominal angiogram showed an ¿aortic injury at the level of the iliac bifurcation.¿ the certificate of death for the patient listed the causes of death to be vascular injury, with an approximate interval: onset of death of 12 hours, atherosclerosis with an approximate interval: onset of death of 10 years, and peripheral arterial disease with an approximate interval: onset of death of 10 years.

Manufacturer Narrative

H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records 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.H10: d4 (expiry date: 08/2024).H11: section a through f ¿ the information provided by bd represents all 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.

Manufacturer Narrative

H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records 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.H10: b5, d4 (expiry date: 08/2024), h6 (patient).H11: section a through f ¿ the information provided by bd represents all 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 the male patient sustained a catastrophic aortic injury during an interventional radiology procedure (an arteriogram) and ultimately died from complications of this injury. the interventional radiologist that performed the arteriogram reported that the atherectomy system used during the procedure was ¿found to have broken off in the patient¿.The physician notes state that an abdominal angiogram showed an ¿aortic injury at the level of the iliac bifurcation".The certificate of death for the patient listed the causes of death to be vascular injury, with an approximate interval: onset of death of 12 hours, atherosclerosis with an approximate interval: onset of death of 10 years, and peripheral arterial disease with an approximate interval: onset of death of 10 years.Additional information was provided by the physician reporting that while retracting the atherectomy system upon completion of removal of the plaque from the lower extremity, the catheter device either unraveled or stripped, causing the patient to suffer an aortic hemorrhage.The physician reported that they were able to immediately control the bleed with an occlusive balloon and transferred patient to a hospital for vascular surgery.However, despite the vascular surgeon's efforts, patient expired the next day while in the intensive care unit.

• Brand Name: ROTAREX
• Type of Device: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18423808
• MDR Text Key: 331766480
• Report Number: 3008439199-2023-00234
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80237
• Device Lot Number: 220872
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White