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

Model Number SET ROTAREX®S 6F X 110CM

Device Problems Break (1069); Fracture (1260)

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

Event Date 11/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6) 2020 @ 8.00 pm.Doctor has punctured at right femoral artery to proximal sma lesion and gave heparin 4,800 iu.He has used rotarex 6f 110 cm after 5 passes, he has pulled it out from the patient and find out that head of rotarex was broken from catheter.

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: 11042775
• MDR Text Key: 227740244
• Report Number: 3008439199-2020-00071
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2023
• Device Model Number: SET ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80219
• Device Lot Number: 200547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR