MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number	80219
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo, image, and video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2027).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a thrombectomy and atherectomy procedure in the occluded left lower extremity femoral artery via the right femoral artery, the waste liquid bag was allegedly found to have no liquid reflux during the suction process.It was further reported that after the catheter was withdrawn, the spring at the tip of the catheter was allegedly found to be damaged.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a thrombectomy and atherectomy procedure in the occluded left lower extremity femoral artery via the right femoral artery, the waste liquid bag was allegedly found to have no liquid reflux during the suction process.It was further reported that after the catheter was withdrawn, the spring at the tip of the catheter was allegedly found to be damaged.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the catheter was returned for evaluation and a physical investigation was performed for the catheter.During physical investigation, the helix head part was peeking out 10 cm from the tip of the catheter.The helix was removed from the tube and found broken at 115.2 cm, which is right at the kink protection.The tube at the kink protection did not show any damages.Helix break of the catheter was observed during investigation.Therefore, the investigation is confirmed for the reported helix break issue.A clear root cause could not be identified but catheter helix break represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: (expiration date: 10/2027).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ROTAREX
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19632428
• Report Number: 3008439199-2024-00109
• Device Sequence Number: 18276584
• Product Code: MCW
• UDI-Device Identifier: 30382903665939
• UDI-Public: (01)30382903665939(11)230207(17)271026(10)220599
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 80219
• Device Lot Number: 220599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown