MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number UNKNOWN

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems Sepsis (2067); Rupture (2208); Obstruction/Occlusion (2422); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/04/2021

Event Type  Death  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.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 (b)(6) 1900 for the mdr submission requirement.Device not returned.

Event Description

It was reported that during the procedure, the device allegedly had retraction problem, distal tip of the wire coiled and detached.It was further reported that the patient allegedly experienced edema, infection, sepsis, occlusion and vessel rupture.The patient allegedly died due to multiorgan failure associated with sepsis after two weeks of the procedure and it was unknown whether the device contribute to his death.The patient was expired.

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: the lot number was reported as unknown, therefore, manufacturing review could not be conducted.Investigation summary: the sample was not returned for evaluation.However, pictures were provided for review.The user report states that during the intervention the guidewire passed subintimal what is against the instruction for use.A subintimal placement of the guidewire is probable to cause a perforation of the vessel wall when the catheter is guided subintimal.The blood flow was recovered successfully but the guidewire mangled with the vessel wall and could be retrieved only with effort.As seen on the pictures the tip of the guidewire unwind and patients tissue was attached.Due to the pictures provided in the published paper, it can be confirmed there was a deformation of the guidewire tip.It is assumed that upon retrieval the guidewire mangled in the passage where it was placed subintimal and for this reason couldn't be retrieved easily.The perforation could have been caused by the mangled guidewire or the catheter that was lead subintimal.The investigation is confirmed for retraction issue and inconclusive for detachment.The definite root cause is unknown.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: g3, h6 (patient).H11: h6 (method, 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.H3 other text : device not returned.

Event Description

It was reported that during the procedure, the device allegedly had retraction problem, distal tip of the wire coiled and detached.It was further reported that the patient allegedly experienced edema, infection, sepsis, occlusion and vessel rupture.The patient allegedly expired due to multiorgan failure associated with sepsis after two weeks of the procedure and it was unknown whether the device contribute to his death.

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: the lot number was reported as unknown, therefore, manufacturing review could not be conducted.Investigation summary: the sample was not returned for evaluation.However, pictures were provided for review.The user report states that during the intervention the guidewire passed subintimal what is against the instruction for use.A subintimal placement of the guidewire is probable to cause a perforation of the the vessel wall when the catheter is guided subintimal.The blood flow was recovered successfully but the guidewire mangled with the vessel wall and could be retrieved only with effort.As seen on the pictures the tip of the guidewire unwind and patients tissue was attached.It is assumed that upon retrieval the guidewire mangled in the passage where it was placed subintimal and for this reason couldn't be retrieved easily.The perforation could have been caused by the mangled guidewire or the catheter that was lead subintimal.Due to the pictures provided in the published paper, it can be confirmed there was a deformation of the guidewire tip.The definite root cause is unknown.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.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 the procedure, the device allegedly had retraction problem, distal tip of the wire coiled and detached.It was further reported that the patient allegedly experienced edema, infection, sepsis, occlusion and vessel rupture.The patient allegedly expired due to multiorgan failure associated with sepsis after two weeks of the procedure and it was unknown whether the device contribute to his death.

• 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: 12098303
• MDR Text Key: 259367088
• Report Number: 3008439199-2021-00112
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 11/15/2021; 02/14/2022
• Supplement Dates FDA Received: 12/08/2021; 02/17/2022
• 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
• Treatment: TABAXIN
• Patient Outcome(s): Required Intervention; Other; Death
• Patient Age: 87 YR
• Patient Sex: Male