MAUDE Adverse Event Report: BD STRAUB MEDICAL / STRAUB MEDICAL AG. BD SET ROTAREX S 6F 135 CM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number S 6 FR 135 CM REF 80237

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2022

Event Type  Injury  

Event Description

A stenosis of the right popliteal artery was being treated with the bard rotarex atherectomy device.Approximately, 18 cm of the metallic drive shaft detached from the device during the procedure and needed to be removed from his popliteal artery.Frequency: single use device.Route: intra-arterial.Fda safety report id# (b)(4).

• Brand Name: BD SET ROTAREX S 6F 135 CM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BD STRAUB MEDICAL / STRAUB MEDICAL AG.
• MDR Report Key: 14311751
• MDR Text Key: 291206381
• Report Number: MW5109558
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: 01076401428105821724073110
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2022

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: S 6 FR 135 CM REF 80237
• Device Catalogue Number: 01076401428105821724073110
• Device Lot Number: 220159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White