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

Model Number ROTAREX®S 6F X 110CM

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event Description

The patient had a closure in the afs segment in a supera stent.A 6f 11cm terumo sheath was used.The thrombotic occlusion was good to pass using a v18 control recanalization wire.The wire was then exchanged for a 0018 "rotarex wire.After successful wire passage, a 6f 110cm rotarex was introduced.After 5000 ie heparin, the intervention was started.In the middle of the closure, the rotarex stopped and didnt work again.The catheter was recovered without problems.However, the patient then had a perforation.This could then be closed with a viabahn.They open the passage with another 6f 110cm rotarex.They can open the passage completed without any problems.However, no further problems arose from this situation.The catheter was properly prepared.

Manufacturer Narrative

Evaluation summary report attached in german was translated to english.

• 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: 11195495
• MDR Text Key: 227589113
• Report Number: 3008439199-2021-00007
• 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: 12/21/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80219
• Device Lot Number: 201203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 85