MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80237

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976); Device Handling Problem (3265)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that during a recanalization procedure in the superficial artery, the device allegedly clutched out within the stents.It was further reported that the helix allegedly fractured.Reportedly, the catheter was retrieved and then the fractured portion retrieved separately by advancing the sheath, clamping the proximal end.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: 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.H10: d4 (expiry date: 07/2026).H11: section a through f: the information provide 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 artery via right to left through common femoral artery contralateral approach, the device allegedly clutched out within the stents.It was further reported that the helix allegedly fractured.Reportedly, the catheter was retrieved and then the fractured portion was retrieved separately by advancing the sheath and clamping the proximal end.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: 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 physical investigation was performed for the catheter.The catheter was sent with the guidewire inside, collecting bag and introducer sheath attached.A foreign guidewire was delivered.The coating of the guidewire was peeled off and a strong kink was observed.During physical investigation, the helix was broken at 58 cm distance from the tip of the catheter.The tube was kinked at the same position at 58 cm from the tip of the catheter.The introducer sheath was found broken 35 cm from the tip of it.Therefore, the investigation is confirmed for the reported break and detachment 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: b5, d4 (expiry date: 07/2026), h6 (device).H11: h6 (method, result, conclusion).H11: section a through f: the information provide 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.

• 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: 18630455
• MDR Text Key: 334546974
• Report Number: 3008439199-2024-00009
• 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: 03/26/2024

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: 80237
• Device Lot Number: 231400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/28/2024
• 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