MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Model Number VERSION 1.0

Device Problems Break (1069); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Perforation of Vessels (2135)

Event Date 05/04/2023

Event Type  Death  

Manufacturer Narrative

Date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.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.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2024).Section a through f: the information provide 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 an atherectomy procedure, while removing the catheter from the sheath, the head of the catheter allegedly broke and migrated.Therefore, a snare device was used to remove the broken piece; however, as the segment was being removed the vessel perforated causing internal bleeding.Reportedly balloon tamponade was performed to stop the bleeding.The patient was then transferred to the hospital for surgery but expired after having surgery to bypass the affected area.Patient¿s cause of death is unknown.

Manufacturer Narrative

Date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.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.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 not returned for evaluation.A physical investigation is not possible.The user report contains information regarding break, migration and detachment of device or device component.The provided pictures do not show any of the mentioned failures.Due to insufficient information the reported failure modes can not be confirmed.Therefore, the investigation is inconclusive for the reported issue.The definitive root cause could not be determined based upon available information.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.B5, d4 (expiry date: 08/2024).H11: section a through f: the information provide 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 contralateral approach atherectomy procedure in the superficial femoral artery through the left common femoral artery, while removing the catheter from the sheath, the head of the catheter allegedly broke and migrated.Therefore, a snare device was used to remove the broken piece; however, as the segment was being removed the vessel perforated causing internal bleeding.Reportedly balloon tamponade was performed to stop the bleeding.The patient was then transferred to the hospital for surgery but expired after having surgery to bypass the affected area.Patient¿s cause of death is 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: 17029053
• MDR Text Key: 316192605
• Report Number: 3008439199-2023-00087
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• 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: 220772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• 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): Death