MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80202

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

It was reported that during a recanalization procedure, when the device was activated at the overlap of stents, a disengaged noise was allegedly heard.It was further reported that the surgeon stopped the activation and when the device was removed from the patient, the helix was allegedly found to be not connected and was separated from the catheter.Reportedly, the broken helix was pulled out of the sheath and the segment was ballooned and then restented.There was no reported patient injury.

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: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration 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: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.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 not returned for evaluation.Therefore, a physical investigation was not possible.Images were provided for review.The user provided report and images show a broken helix of the catheter.Therefore, the investigation is confirmed for the reported helix break.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.H10: d4 (expiration date: 08/2024), g3.H11: 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.

Event Description

It was reported that during a recanalization procedure, when the device was activated at the overlap of stents, a disengaged noise was allegedly heard.It was further reported that the surgeon stopped the activation and when the device was removed from the patient, the helix was allegedly found to be not connected and was separated from the catheter.Reportedly, the broken helix was pulled out of the sheath and the segment was ballooned and then restented.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: 17876148
• MDR Text Key: 324981227
• Report Number: 3008439199-2023-00167
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80202
• Device Lot Number: 220822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/07/2023
• 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