MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Model Number VERSION 1.0

Device Problems Break (1069); Overheating of Device (1437)

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

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.Medical device: expiry date: 11/2023.

Event Description

It was reported that during a recanalization procedure in right groin access up and over contralateral approach, the catheter was allegedly heated.It was further reported that catheter was removed and noticed that the guidewire allegedly broken.Reportedly distal segments are removed from the patient.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 sample was returned for evaluation.The guidewire was broken and the guidewire tip decoiled.The helix was pointing out from the catheter.The tube was damaged at two positions, at 85 cm and 95 cm from the tip.A dense occlusion in catheter was observed at 10 cm to 20 cm distance from the tip.The investigation is confirmed for reported issues.A clear root cause could not be identified but a broken guidewire represents a known inherent risk.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: 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: d4 (expiry date: 11/2023), g3.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 in right groin access up and over contralateral approach, the catheter was allegedly heated.It was further reported that catheter was removed and noticed that the guidewire allegedly broken.Reportedly distal segments are removed from the patient.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: 13867896
• MDR Text Key: 290458532
• Report Number: 3008439199-2022-00019
• 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: 03/24/2022

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 Model Number: VERSION 1.0
• Device Catalogue Number: 80237
• Device Lot Number: 210055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 05/24/2022
• 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 Sex: Female
• Patient Weight: 71 KG