MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number UNK ROTAREX

Device Problem Break (1069)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2022

Event Type  Injury  

Event Description

It was reported in an article in journal of ¿rofo¿ titled ¿safety and efficacy of rotational thrombectomy for treatment of arterial occlusions of the lower extremities: a large single-center retrospective study", approximately sometime post procedure, a device deficiency in two out of three hundred and ninety seven interventions were observed.It was further reported that eleven patients had vessel perforation, five patients developed iatrogenic arteriovenous fistula, eight patients had vascular dissection, and two patients had miscellaneous procedural complications out of three hundred and ninety seven interventions.The current status of the patient is unknown.

Manufacturer Narrative

The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.As this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of twenty-eight for this event.As the lot number for the device was not provided, a review of the device history records could not 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) are 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.Christoph, artzner, isabelle martin, gerald hefferman, kerstin artzner, mario lescan, rick de graaf et al., (2022) safety and efficacy of rotational thrombectomy for treatment of arterial occlusions of the lower extremities: a large single-center retrospective study.Fortschr röntgenstr.Doi: 10.1055/a-1952-0092.Device not returned.

• 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: 16396837
• MDR Text Key: 309752513
• Report Number: 3008439199-2023-00010
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ROTAREX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• 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
• Treatment: ACETYLSALICYLIC ACID.; CLOPIDOGREL.; HEPARIN.
• Patient Outcome(s): Required Intervention