MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80239

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  Death  

Manufacturer Narrative

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.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.Date of death for this patient was not provided, date of death updated as 01-jan-1900 for the mdr submission requirement.(expiry date: 03/2024).Device not returned.

Event Description

It was reported that during an aorta iliac procedure, the physician allegedly cut along the dissection plane and the patient was deceased.

Event Description

It was reported that during an aorta iliac procedure, the physician allegedly cut along the dissection plane and the patient was deceased.

Manufacturer Narrative

H10: date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.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 not returned for evaluation.The user report states that the iliac arteries were treated what is against the instruction for use because they are not part of the peripheral arteries.The physician has cut along the dissection plane (subintimal) thinking it was the lumen and the patient died due to this.There was no quality issue or malperformance reported with the device.When working in the iliac arteries a rupture can easily lead to death because these vessels have a wide diameter and carry a big amount of blood.Due to the position inside the patients torso, no compression can be applied to stop the bleeding.In such case the patient can bleed to death within minutes.Apart from that the subintimal guidance of the catheter is also a use error and against the instruction for use."warnings".When using the catheter off label it is the physician responsibility to outweigh the risks and benefits of the treatment.This case is an off label use combined with a use error.The patient death is not related to the performance or quality of the rotarex device.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: 03/2024), g3, h6 (method).H11: h6 (device, result, conclusion).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.

Manufacturer Narrative

H10: the initial mdr was inadvertently submitted with a g3 date of 09/07/2021.The correct g3 date is 09/08/2021.H10: date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.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 not returned for evaluation.The user report states that the iliac arteries were treated what is against the instruction for use because they are not part of the peripheral arteries.The physician has cut along the dissection plane (subintimal) thinking it was the lumen and the patient died due to this.There was no quality issue or malperformance reported with the device.When working in the iliac arteries a rupture can easily lead to death because these vessels have a wide diameter and carry a big amount of blood.Due to the position inside the patients torso, no compression can be applied to stop the bleeding.In such case the patient can bleed to death within minutes.Apart from that the subintimal guidance of the catheter is also a use error and against the instruction for use."warnings".When using the catheter off label it is the physician responsibility to outweigh the risks and benefits of the treatment.This case is an off label use combined with a use error.The patient death is not related to the performance or quality of the rotarex device.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: 03/2024), g3 h11: b3 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.Device not returned.

Event Description

It was reported that during an aorta iliac procedure the physician allegedly cut along the dissection plane and the patient was deceased.

• 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: 12567162
• MDR Text Key: 274419434
• Report Number: 3008439199-2021-00162
• Device Sequence Number: 1
• Product Code: MCW
• 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,Followup
• Report Date: 12/14/2021

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: 80239
• Device Lot Number: 210902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 12/07/2021; 12/14/2021
• Supplement Dates FDA Received: 12/08/2021; 12/16/2021
• 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