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

Model Number SET ROTAREX®S 6F X 135CM

Device Problems Retraction Problem (1536); Use of Device Problem (1670)

Patient Problems Perforation (2001); Perforation of Vessels (2135); Stenosis (2263)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

No issues to note during setup.Dr.(b)(6) ]had left cfa access with a 7f 45cm terumo destination up and over parked in the left cfa.He crossed a distal sfa to mid popliteal lesion with an 035 quick cross and glidewire advantage.There was a single vessel distal run off (peroneal) which was selected with the glidewire and quick cross.The glidewire was swapped for the contained 018 straub wire which was placed in the distal peroneal.The rotarex catheter was then inserted through the 7f destination sheath and tracked to the distal sfa with no issue.Dr.(b)(6) activated the rotarex catheter 1cm proximal to the first lesion in the distal sfa and ran the catheter with a "chew and swallow" technique as he traversed the length of the lesion.At the most distal part of the lesion in the mid popliteal the clutch disengaged several times as he tried to pass through the 99% stenosis.After several attempts he passed through the distal lesion and finished the atherectomy, leaving the device active he pulled back to the starting point.Then dr.(b)(6) took a picture using digital subtraction to visualize the post rotarex result.A perforation in the mid popliteal was noted - as dr.(b)(6) tried to remove the rotarex, he stated it would not track back over the wire so he pulled both the rotarex and wire out simultaneously.He re-crossed the lesion with the glidewire and subsequently a 4x120 angioplasty balloon was inflated for 5 minutes.The perforation did not improve and after another 3 minute inflation dr.(b)(6) decided to use a 5x5cm viabahn covered stent to tack up the perforation.He deployed the stent and post dilated with a 4x40 pta balloon - after which no extravasation was noted.Dr.(b)(6) treated a proximal sfa lesion with a lutonix 4x60 and then took a final angiogram to confirm the distal vessels were patent.Dr.(b)(6) completed the procedure with a 6/7 mynx closure device.The patient was doing well post procedure and no issues noted in recovery.

Manufacturer Narrative

Summary evaluation report attached.Added data to d8 and d9 and correction of initial reporter.

• 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: 10230903
• MDR Text Key: 197574881
• Report Number: 3008439199-2020-00011
• 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: 06/12/2020

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: 01/11/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80237
• Device Lot Number: 200136
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/04/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention