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

Model Number SET ROTAREX®S 6F X 110CM

Device Problems Use of Device Problem (1670); Noise, Audible (3273)

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

Event Date 09/28/2020

Event Type  malfunction  

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.At the beginning, blood was found flowing out.After around one minute, strange sound was heard.Stop the motor and take it out, and flushed again with guildwire.Catheter was very hot and guildwire was stuck to the catheter.Another new catheter was used to complete the operation.

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: 10906277
• MDR Text Key: 218956250
• Report Number: 3008439199-2020-00062
• 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

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 58