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

Catalog Number 80219

Device Problems Break (1069); Leak/Splash (1354); Detachment of Device or Device Component (2907); Material Deformation (2976); Mechanical Jam (2983)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported that during a recanalization procedure for mid femoral arterial stent occlusion, through the right groin femoral artery access, while inserting the catheter into the sheath, a spray of clear liquid was noted from the catheter.It was further reported that the catheter appeared to have a hole that was spraying out the flush and the catheter was removed, and a second catheter was loaded.Furthermore, when the physician pressed the trigger to flush the catheter, the wire allegedly got snapped with the distal end in the foot and the proximal tip was within the sheath.Reportedly, the patient allegedly had a cut down performed to retrieve the wire from the posterior tibial artery and a new catheter was used.The patient was currently in stable condition.

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: 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 is currently being performed.The return of the sample is pending.However, a video, an image and photos were provided for review.The investigation of the reported event is currently underway.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 Description

It was reported that during a recanalization procedure for mid femoral arterial stent occlusion, through the right groin femoral artery access, while inserting the catheter into the sheath, a spray of clear liquid was noted from the catheter.It was further reported that the catheter appeared to have a hole that was spraying out the flush and the catheter was removed, and a second catheter was loaded.Furthermore, when the physician pressed the trigger to flush the catheter, the wire allegedly got snapped with the distal end in the foot and the proximal tip was within the sheath.Reportedly, the patient allegedly had a cut down performed to retrieve the wire from the posterior tibial artery and a new catheter was used.The patient was currently in stable condition.

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 physical sample was returned for evaluation and a catheter was physically investigated.During physical investigation the guidewire was delivered inside of the catheter without any physical damages on it.A lot of coagulated material was observed inside of the catheter handle.The test guidewire passed with the slight resistance.After running in the water nominal aspiration level was achieved.The reported break or deformation was not observed.Leak of the catheter was not observed the catheter was only blocked with coagulated material.Therefore, the investigation is unconfirmed for the reported leak, material deformation, beak and detachment issues and is confirmed for the identified mechanical jam.A clear root cause could not be identified but a blockage of the catheter 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.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
• Type of Device: 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: 18795115
• MDR Text Key: 336395171
• Report Number: 3008439199-2024-00035
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80219
• Device Lot Number: 231084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention