MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number	80236
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: 07/2024).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.H3 other text : device not returned.
Event or Problem Description
It was reported in an article in the journal of ¿intensive cardiology¿ titled ¿dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound", that after two runs of device in the occluded right distal superficial femoral artery, the patient reportedly had vessel perforation.It was further reported that the patient underwent additional medical intervention for bail-out stent placement with post-dilatation.Reportedly, the patient was recovered with zero percent final residual narrowing.The current status of the patient is unknown.
Event or Problem 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 two runs of device in the occluded right distal superficial femoral artery, the patient reportedly experienced vessel perforation.It was further reported that the patient underwent additional medical intervention for bail-out stent placement with post-dilatation.Reportedly, the patient was recovered with zero percent final residual narrowing.The current status of the patient is unknown.
Additional 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 returned for evaluation and a physical investigation was not possible.The user report and provided image contains information regarding catheter mechanical jam.Due to no sample the failure mode cannot be confirmed.Therefore, the investigation is inconclusive 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: 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: 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: 07/2024), g3, h6 (method).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.H3 other text : device not returned.
Event or Problem 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 two runs of device in the occluded right distal superficial femoral artery, the patient reportedly experienced vessel perforation.It was further reported that the patient underwent additional medical intervention for bail-out stent placement with post-dilatation.Reportedly, the patient was recovered with zero percent final residual narrowing.The current status of the patient is unknown.
Additional 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 returned for evaluation and a physical investigation was not possible.The user report and provided image contains information regarding catheter mechanical jam.Due to no sample the failure mode cannot be confirmed.Therefore, the investigation is inconclusive 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: 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: 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: 07/2024), g3.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.H3 other text : device not returned.

• Brand Name: ROTAREX
• Common Device Name: 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: 17697217
• Report Number: 3008439199-2023-00145
• Device Sequence Number: 7446385
• Product Code: MCW
• UDI-Device Identifier: 07640142810575
• UDI-Public: (01)07640142810575
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 80236
• Device Lot Number: 220500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 12/07/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 11/20/2023; 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White