MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80237

Device Problems Break (1069); Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2026).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 in the superficial femoral artery, the device allegedly had a quick brief pitch change and then stopped working.It was further reported that the tip and part of the helix was allegedly found to be broken upon removal and was left in the patient.Reportedly, the broken part was successfully removed with a snare device.There was no reported patient injury.

Manufacturer Narrative

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 physical sample was not received for evaluation and a physical investigation was not possible.The user report contains information regarding helix break.Due to no sample/pictures/videos received the reported malfunction cannot be confirmed.Therefore, the investigation is inconclusive for the reported break, detachment and noise issues.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 04/2026), g3, h6 (method) h11: b5, d3, g1, h6 (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.

Event Description

It was reported that during a thrombectomy and atherectomy procedure in the superficial femoral artery via the femoral access, the device allegedly had a quick brief pitch change and then stopped working.It was further reported that the tip and part of the helix was allegedly found to be broken upon removal and was left in the patient.Reportedly, the broken part was successfully removed with a snare device.The procedure was completed using another device.There was no reported patient injury.

• 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: 18891730
• MDR Text Key: 337558479
• Report Number: 3008439199-2024-00042
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: (01)07640142810582
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80237
• Device Lot Number: 230898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• 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