MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80237

Device Problems Material Separation (1562); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem Perforation of Vessels (2135)

Event Date 07/10/2023

Event Type  Injury  

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 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 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.H3 other text : device not returned.

Event Description

It was reported that during the recanalization procedure in the distal popliteal and tibioperoneal trunk, the device was allegedly clutched out and adhered to the guidewire.It was further reported that the device was extremely difficult to remove over the guidewire and was retracted to pull the wire back from the lesion.It was also reported that as the device was being withdrawn, the catheter tip was allegedly separated from the catheter.Reportedly, the device had created a perforation of the artery and required surgery to fix the perforation.The current status of the patient was unknown.

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: 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 catheter was returned for evaluation and was physically investigated.There was no physical damage noted on the catheter.The test guidewire was difficult to pass due to coagulated material inside of the catheter.It was not possible to run the catheter.The helix of the catheter was investigated and found heavily blocked with a lot of coagulated material on it.Therefore the investigation is confirmed for the reported mechanical jam and physical resistance, and the investigation is unconfirmed for the reported material seperation.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.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: d4 (expiry date: 11/2024), g3.H11: h6 (method, result, conclusion).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 Description

It was reported that during the recanalization procedure in the distal popliteal and tibioperoneal trunk, the device was allegedly clutched out and adhered to the guidewire.It was further reported that the device was extremely difficult to remove over the guidewire and was retracted to pull the wire back from the lesion.It was also reported that as the device was being withdrawn, the catheter tip was allegedly separated from the catheter.Reportedly, the device had created a perforation of the artery and required surgery to fix the perforation.The current status of the patient was unknown.

• Brand Name: ROTAREX
• Type of Device: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17467912
• MDR Text Key: 320473936
• Report Number: 3008439199-2023-00125
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: (01)07640142810582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 80237
• Device Lot Number: 230323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/18/2023
• 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