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); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Use of second device during this procedure is described and investigated in 3008439199-2020-00022.

Event Description

Gained access on left common fem to treat right sfa.Left common fem was heavily calcified so a short 4mm balloon was used to predilate the cfa in order to insert the sheath.A 6x45 cook ansel was run up and over.Dr.(b)(6) crossed a cto in the distal sfa with a wire/catheter.A 135cm rotarex was then inserted and run down to the distal sfa to treat the lesion that was just crossed.After a minute or so of running, the audible sound from rotarex changed letting us know there was a problem.It was identified that fluid was not being sucked into the collection bag so it was decided to remove the device from the patient.During removal we noticed the cook sheath had prolapsed up into the aorta.I asked dr.(b)(6) if he thought this was a steep bifurcation to which he said no and pulled the sheath back down to show a nice arc shape over the bifurcation.Upon removal the tip of the rotarex was placed in saline to run and it would not aspirate.Use of second device during this procedure is described and investigated in 3008439199-2020-00022.

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: 10319387
• MDR Text Key: 207417296
• Report Number: 3008439199-2020-00021
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1