MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80237

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Perforation of Vessels (2135)

Event Date 02/23/2023

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.H10: nicolas w.Shammas, james t.Torey, and w.John shammas (2018).Dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound.Journal of invasive cardiology, 30(4): 145-146.H10: d4 (expiration date: 07/2023).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 in an article in the journal of ¿invasive cardiology¿ titled ¿dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound", that after one run of device in the occluded distal popliteal artery, the patient allegedly complained of pain.It was further reported that the angiogram revealed, the patient allegedly had vessel perforation of one centimeter above the original lesion.Furthermore, the patient underwent additional medical intervention for covered stent placement with post dilatation.Reportedly, the patient was recovered with less than ten percent residual narrowing.The current status of the patient is unknown.

Event Description

It was reported in an article in the journal of ¿invasive cardiology¿ titled ¿dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound", that after one run of device in the occluded distal popliteal artery, the patient allegedly complained of pain.It was further reported that the angiogram revealed, the patient allegedly experienced vessel perforation of one centimeter above the original lesion.Furthermore, the patient underwent additional medical intervention for covered stent placement with post dilatation.Reportedly, the patient was recovered with less than ten percent residual narrowing.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 physical sample was not received for evaluation and a physical investigation was not possible.The user report contains information regarding the adverse event without identified device or use problem.Therefore, the investigation is confirmed for the reported failure.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.H10: nicolas w.Shammas, james t.Torey, and w.John shammas (2018).Dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound.Journal of invasive cardiology, 30(4): 145-146.H10: d4 (expiration date: 07/2023), g3, h6 (method) h11: b3 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): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17770882
• MDR Text Key: 323682797
• Report Number: 3008439199-2023-00148
• Device Sequence Number: 1
• Product Code: MCW
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• 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: 201041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White