MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Model Number VERSION 1.0

Device Problems Break (1069); Failure to Advance (2524); Detachment of Device or Device Component (2907)

Patient Problems Low Blood Pressure/ Hypotension (1914); Foreign Body In Patient (2687)

Event Date 01/10/2022

Event Type  Injury  

Event Description

It was reported that during a recanalization procedure in the right superficial femoral artery, the guidewire was allegedly unable to cross lesion.It was further reported that tip of the guidewire was broken and detached into patient's distal aorta.Reportedly, patient's blood pressure was dropping.The guide wire was still in the patient's aorta.The current status of the patient is unknown.

Manufacturer Narrative

The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.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.The investigation of the reported event is currently underway.(expiration date: 05/2024).Device pending return.

Event Description

It was reported that during a recanalization procedure in the right superficial femoral artery, the guidewire was allegedly unable to cross lesion.It was further reported that tip of the guidewire was broken and detached into patient's distal aorta.Reportedly, patient's blood pressure was dropping.The guide wire was still in the patient's aorta.The current status of the patient is 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: the sample was returned for evaluation.A physical investigation was performed for the catheter.The guidewire, that was reported as broken, was not delivered.It was observed that the catheter was occluded and aspiration could not be achieved.A possible reason for the reported breakage of the guidewire is the observed clogging of the catheter.When the catheter is clogged, the guidewire and the helix are attached to each other and tend to rotate along together.To prevent such clogging it is recommend to make sure there is sufficient drainage flow from the catheter.Sufficient dosage of heparin, moving the catheter back and forth during the intervention as well as addition of saline help to stabilize the drainage flow.It is recommended to have a second operator to control the flow of aspirated material into the collecting bag.¿the investigation is confirmed for the reported break issue.A clear root cause could not be identified but a broken guidewire 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: 05/2024), 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.

• Brand Name: ROTAREX
• Type of Device: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13448458
• MDR Text Key: 285034997
• Report Number: 3008439199-2022-00002
• 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: K172315
• 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: 02/22/2022

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 Model Number: VERSION 1.0
• Device Catalogue Number: 80237
• Device Lot Number: 211253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 02/24/2022
• 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; Other