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

Catalog Number	80201
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2026).H11: section a through f - the information provided by bd represents all of 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, the catheter allegedly broke.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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 physical device was returned for evaluation and a physical investigation was performed for the catheter.During physical investigation, the helix was broken at 51 cm distance from the tip of the catheter.Also, the tube was damaged at 51.5 cm from the tip of the catheter and the helix was peeking out of the break.The reported mechanical jam was not observed during investigation and could not be reproduced therefore, can not be confirmed.Therefore, the investigation is confirmed for the reported helix break issue.The definitive root cause could not be determined based upon provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 middle portion of the superior mesenteric artery via the right femoral artery approach, the catheter allegedly became clogged.It was further reported that the catheter allegedly broke.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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 physical device was returned for evaluation and a physical investigation was performed for the catheter.During physical investigation, the helix was broken at 51 cm distance from the tip of the catheter.Also, the tube was damaged at 51.5 cm from the tip of the catheter and the helix was peeking out of the break.The reported mechanical jam was not observed during investigation and could not be reproduced therefore, cannot be confirmed.Therefore, the investigation is confirmed for the reported helix break issue.The definitive root cause could not be determined based upon provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, d4 (unique identifier (udi) #).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 middle portion of the superior mesenteric artery via the right femoral artery approach, the catheter allegedly became clogged.It was further reported that the catheter allegedly broke.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: a voluntary recall has been initiated for the rotarex atherectomy system.The atherectomy catheter eifu was updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events.Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.As part of an internal investigation, this event was reviewed in collaboration with our medical affairs team.Based on the findings, it has been determined that the event meets the criteria for a serious injury as defined under 21 cfr 803.3.Accordingly, we are submitting this report to reflect the upgraded classification.Please refer to section b5 of this report for a detailed event description and rationale for the reclassification.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 physical device was returned for evaluation, and a physical investigation was performed for the catheter.During physical investigation, a helix break was found 51 cm from the tip, and tube damage was observed at 51.5 cm, with the helix protruding from the break.The reported mechanical jam could not be reproduced or confirmed.The investigation confirmed the helix break; however.The definitive root cause could not be determined based upon provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (expiry date: 12/2023), g3.B1, b2, b5, h1, h6 (patient).Section a through f: the information provide 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 during an emergency endovascular procedure to treat a sub occlusive thrombus in the superior mesenteric artery (sma) of a coronary patient at risk of mesenteric ischemia, the rotarex thrombectomy probe broke during the procedure.After an initial pass, the catheter became clogged and was flushed with heparinized saline.During a second pass, the catheter ceased functioning and was removed, at which point it was discovered that the catheter component had fractured.As a result, the procedure was interrupted and the thrombectomy could not be completed.There were no reported clinical signs or consequences to the patient.

• 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: 19057222
• Report Number: 3008439199-2024-00054
• Device Sequence Number: 6593302
• Product Code: MCW
• UDI-Device Identifier: 07640142810292
• UDI-Public: (01)07640142810292(10)231950
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 80201
• Device Lot Number: 231950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 06/02/2025; 06/08/2025
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/05/2024; 06/04/2025; 06/20/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1244-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown