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); Use of Device Problem (1670)

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

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event Description

Access was obtained with ultrasound and a micro puncture kit via the left femoral artery.A 150cm standard j wire was introduced into the micro puncture sheath, and then the micro puncture sheath was replaced with a 6f 10cm pinnacle sheath.An aortagram with runoff was performed with a pigtail catheter.A noncalcific right eccentric sfa lesion was identified.Collectively we then decided that the bifurcation was very favorable for rotarex, and then the physician exchanged the 6f pinnacle sheath with a 6fx45cm cook high flex ansel sheath.We then used a multipurpose catheter and 300cm glide wire to cross the lesion, and the physician then exchanged the glide wire for the straub.018 rotarex wire.We then selected a 6fx135cm rotarex, and we took the proper steps with device prep.The device was advanced over the rotarex wire through the cook high flex ansel sheath 1cm proximal to our target lesion.The physician then performed two therapeutic passes with the device.The device performed optimal with no alarming changes in audible pitch.The physician then decided that he provided adequate treatment and decided to remove the device.We informed the physician that the tip of the rotarex catheter will likely separate upon removal from the sheath and that this is not uncommon.Upon removal the rotarex tip was hung up in the valve of the cook high flex ansel sheath and the helix was stretched too far causing a fracture of the helix.Adjunctive therapy was performed with a 5mmx150mm ultrascore balloon which obtained satisfactory angiographic results.The cook high flex ansel sheath was removed and the left femoral artery puncture site was closed with a mynx closure device and manual pressure.

• 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
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer Contact: martin kvokacka ; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10998943
• MDR Text Key: 228419313
• Report Number: 3008439199-2020-00065
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: 7640142810582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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: 04/30/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80237
• Device Lot Number: 200664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 113