MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number ROTAREX®S 6F X 110CM

Device Problems Break (1069); Fracture (1260); No Device Output (1435); Noise, Audible (3273)

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

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event Description

Physician had a rotarex intervention with quiet pointed bifurcation.He used a destination sheath.After starting the motor inside the stent, he could only work for some seconds before the motor made strange noise and then stopped.He recognized that the catheter was broken.He did not use a second rotarex, he finished the case just with a plain balloon angioplasty.The rotarex catheter was taken out of the patient without any harm.Due to patient was fully stented, there was no possibility in using an antegrade access.That is why physician had to use the crossover access.

Manufacturer Narrative

Evaluation summary report attached in german was translated to english.

• Brand Name: ROTAREXS 6F 110CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 11171171
• MDR Text Key: 227986131
• Report Number: 3008439199-2021-00005
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810285
• UDI-Public: 7640142810285
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80219
• Device Lot Number: 201380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 78