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

Catalog Number	80236
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(b)(4).
Event or Problem Description
It was reported that during the procedure through right common femoral artery, the device allegedly detached while removing the catheter.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.The physical investigation showed the helix was broken at 46 cm distal and the tube was kinked at the same position.Therefore, the investigation is confirmed for the reported detachment issue.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the fda rn number and manufacturing location for the straub product was selected as (b)(4) and unknown due to system limitations.The correct fda rn number and manufacturing location are (b)(4) and straub medical us.D4 (expiry date: 07/2024).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 the procedure through right common femoral artery, the device allegedly detached while removing the catheter.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the fda rn number for the initial mdr was inadvertently submitted as 2020394.The correct fda rn number was 3008439199.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.Thus, a physical investigation was performed for the rotarex catheter.During physical investigation the helix was broken at 46 cm distance from the tip of the catheter.The tube had a kink at the same position at 46cm from the tip of the catheter.It was not possible to specify the root cause further using the information provided by the user.Therefore, it can be confirmed that the helix was broken.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: d2b (mcw; dqx).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 thrombectomy and atherectomy procedure through right common femoral artery, the device allegedly detached while removing the catheter.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ROTAREX
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs AZ 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: 11892007
• Report Number: 2020394-2021-01117
• Device Sequence Number: 17071219
• Product Code: MCW
• UDI-Device Identifier: 07640142810575
• UDI-Public: (01)07640142810575(17)240714(10)200704
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2025

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 Expiration Date: 07/14/2024
• Device Catalogue Number: 80236
• Device Lot Number: 200704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 01/29/2025
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 09/17/2021; 02/03/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 86 KG