MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number UNKNOWN

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

Patient Problems Obstruction/Occlusion (2422); Embolism/Embolus (4438)

Event Date 05/24/2022

Event Type  Injury  

Event Description

It was reported in an article "a case report of distal radial puncture in a patient with acute upper limb ischaemia: the last hope of the cardiologist?", that rotarex mechanical thrombectomy catheter procedure led to relevant peripheral embolization, causing occlusion of both the radial and ulnar arteries.Subsequently, catheter aspiration was performed which led to complete flow restoration in both ulnar and radial arteries of the patient and complete resolution of ischaemic symptoms.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.Sorin giusca, andrej schmidt, grigorios korosoglou (2022).A case report of distal radial puncture in a patient with acute upper limb ischaemia: the last hope of the cardiologist? eur heart j case rep, 24;6(7):ytac215.Doi: 10.1093/ehjcr/ytac215.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

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.Sorin giusca, andrej schmidt, grigorios korosoglou (2022).A case report of distal radial puncture in a patient with acute upper limb ischaemia: the last hope of the cardiologist? eur heart j case rep.;6(7):ytac215.Doi: 10.1093/ehjcr/ytac215.H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the sample was not returned for evaluation and image was not provided for review.Therefore, the investigation is inconclusive for the reported issue.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The instructions for use describes the procedure and shows different cautions and warning regarding embolism.("potential adverse effects" / "preparation for use" / "treatment of the occlusion").Embolism can be a potential adverse effect.If used in an oversized vessel diameter, there is a risk that the thrombus load will exceed the aspiration capacity of the catheter, causing all degrees of severity of embolisation.Advancing the catheter too quickly increases the risk of this advancement mobilising more material than can be aspirated and carried away, which can cause distal embolisation.H11:section a through f - the information provided by bd represents all of 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 in an article "a case report of distal radial puncture in a patient with acute upper limb ischaemia: the last hope of the cardiologist?", that rotarex mechanical thrombectomy catheter procedure led to relevant peripheral embolization, causing occlusion of both the radial and ulnar arteries.Subsequently, catheter aspiration was performed which led to complete flow restoration in both ulnar and radial arteries of the patient and complete resolution of ischaemic symptoms.The current status of the patient is unknown.

• 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: 15334797
• MDR Text Key: 299048894
• Report Number: 3008439199-2022-00116
• 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,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• 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): Other; Life Threatening
• Patient Sex: Female