MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number SET ROTAREX®S 6F X 135CM

Device Problems Break (1069); Fracture (1260)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event Description

Rotarex came apart inside patient.Had to remove catheter using endovascular tricks.No patient harm.6 fr guiding catheter was used to trap the broken helix and subsequently a 2 x 12 coronary balloon was used to trap the helix into the catheter which was then retracted from the patient's body without incident.Once the broken helix was retracted we then angioplasty with both poba and dcb.We then noticed a non-flow limiting dissection in the mid sfa which we tacked up with a 6 x 1 50 mm lifestent.Angiography revealed a good result and the case was completed without further incident.

Manufacturer Narrative

Summary evaluation report attached.

• Brand Name: ROTAREXS 6F 135CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 11046337
• MDR Text Key: 222663400
• Report Number: 3008439199-2020-00072
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: 7640142810582
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80237
• Device Lot Number: 200772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 79