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

Model Number SET ROTAREX®S 6F X 135CM

Device Problems Fracture (1260); Patient-Device Incompatibility (2682)

Patient Problems Embolism (1829); Perforation of Vessels (2135); Great Vessel Perforation (2152); Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Use of first device (previous one) during this procedure is described and investigated in 3008439199-2020-00021.

Event Description

Use of first (previous) device during this procedure is described and investigated in 3008439199-2020-00021.Dr.(b)(6) decided a second device was appropriate at this time.The 2nd device was run up and over without incident and down to the lesion.Again, after a minute or so, the clutch began to slip o rotarex.Dr.(b)(6) decided it would be appropriate to put a 4mm balloon down so he began removing the device.As he was removing, he noticed that the tip of rotarex was not moving with the catheter.He examined the catheter under flouro and we couldn't see if it was broken so he continued with trying to remove the device slowly.As he removed rotarex, he was not feeling any resistance and it was determined the helix was no longer attached.He was able to snare the helix in an attempt to pull it out through the sheath.Dr.(b)(6) was able to get the tip pulled back up to the right cfa before the patient complained of discomfort in his right groin area.At that time dr.(b)(6) decided to do a cut down of the right cfa to remove the helix.When dr.(b)(6) got to the helix he said it still felt stuck and was not coming out easily.At that time it was determined there was a perforation at the bifurcation and he opened the patient up.Dr.(b)(6) was able to retrieve the device after cutting it in half.Patient is in stable condition as of this morning.

Manufacturer Narrative

Added data to d8 and d9 and correction of h6 and evaluation summary report.

• 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: 10319635
• MDR Text Key: 207416246
• Report Number: 3008439199-2020-00022
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80237
• Device Lot Number: 200475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention