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

Catalog Number	80219
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 an atherectomy and thrombectomy procedure, the catheter helix was allegedly fractured.The procedure was completed by 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: a physical investigation was performed for the catheter.During physical investigation the tube was kinked at two positions, at 6.5 cm and 30.5 cm from the tip of the catheter.The head part of the catheter was missing.The helix was found broken at 1.5 cm from the tip of the catheter.A clear root cause could not be established.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 an atherectomy and thrombectomy procedure, the catheter helix was allegedly fractured.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an atherectomy and thrombectomy procedure, the catheter helix was allegedly fractured.The procedure was completed by 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 products that are cleared in the us.The pro code and 510 k number for the rotarex products 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 physical sample was returned for evaluation, and a catheter was physically investigated.During physical investigation the tube was kinked at two positions, at 6.5 cm and 30.5 cm from the tip of the catheter.The head part of the catheter was missing.The helix was found broken at 1.5 cm from the tip of the catheter.A clear root cause could not be established.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3 h11: h3, h6 (conclusion) 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: 20520264
• Report Number: 3008439199-2024-00190
• Device Sequence Number: 12936983
• Product Code: MCW
• UDI-Device Identifier: 07640142810278
• UDI-Public: (01)07640142810278(10)221964
• 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,Followup
• Report Date (Section B): 12/06/2024

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: 230006
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 11/27/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/27/2024; 12/25/2024
• 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