MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number SET ROTAREX®S 6F X 110CM

Device Problems Entrapment of Device (1212); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Suspect device not returned yet.The return of suspect device is expected.

Event Description

Thrombosis was found in sfa.Anterograde puncture was performed.Straub guildwire was used.Syringe was used to flush the catheter before inserting into the body.Guildwire reached 15cm beyond the thrombosis.Catheter reached 2cm before the thrombosis and started the motor.Aspiration and taking out for flushing.The second time, taking out the catheter and found the head of the catheter left in body.Snare was used to take it out but failed.Open surgery was then conducted to take it out.

Manufacturer Narrative

Summary evaluation report attached.

• Brand Name: ROTAREXS 6F 110CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10906682
• MDR Text Key: 218717673
• Report Number: 3008439199-2020-00063
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810285
• UDI-Public: 7640142810285
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: SET ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80219
• Device Lot Number: 200840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 73