MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80219

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

The catalog number 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 common device name.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 the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that during a recanalization procedure for right superficial femoral artery occlusion via right groin, the archimedean screw allegedly broke.The procedure was completed using another device.There was no reported patient 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: 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.A physical investigation was performed for the catheter.The catheter showed a damaged tubing 78.5 cm from tip.Further investigation did not show a broken helix.A test guidewire passed without any resistance.After a couple of runs in water, nominal aspiration level was achieved at 41 ml/min.Therefore, the investigation is not confirmed for the reported break 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.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.

Event Description

It was reported that during a recanalization procedure for right superficial femoral artery occlusion via right groin, the archimedean screw allegedly broke.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: 16483338
• MDR Text Key: 310862319
• Report Number: 3008439199-2023-00028
• 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,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2023

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: 80219
• Device Lot Number: 221874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/04/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/17/2023
• 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