MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80219

Device Problems Retraction Problem (1536); Material Deformation (2976); Mechanical Jam (2983)

Patient Problem Perforation of Vessels (2135)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.

Event Description

It was reported that during a recanalization procedure, the device allegedly disengaged and wire was allegedly could not be removed.It was further reported that patient allegedly experienced perforation of the distal popliteal.Reportedly, the vessel was ballooned then stented to stop the bleeding.The current status of the patient is unknown.

Event Description

It was reported that during a recanalization procedure through the common femoral ipsilateral approach, the device allegedly disengaged and wire allegedly got stuck in the device and could not be removed.It was further reported that patient allegedly experienced perforation of the distal popliteal.Reportedly, the vessel was ballooned and then stented to stop the bleeding.The procedure was completed using another device.The patient is stable now.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.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: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation and a catheter was physically investigated.During physical investigation the catheter was blocked.The guidewire was removed from the catheter and a lot of body material on the guidewire was found.Aspiration test was performed, and nominal aspiration level was achieved.Mechanical jam of the catheter was observed during investigation.The reported material deformation and retraction problem were not observed during investigation.Therefore, the investigation is unconfirmed for the reported material deformation and retraction problem issues.However, the investigation is confirmed for the identified mechanical jam.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (device).H11: b5, h6 (method, result, conclusion).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 : see h10.

• 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: 18665883
• MDR Text Key: 334833490
• Report Number: 3008439199-2024-00013
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80219
• Device Lot Number: 222020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention