MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number UNK ROTAREX

Device Problems Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Sepsis (2067); Perforation of Vessels (2135); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/24/2021

Event Type  Death  

Event Description

It was reported in an article titled "complications associated with the rotarex wire in a patient with peripheral artery disease" that during a recanalization procedure in the superficial femoral artery, the distal wire tip allegedly got coiled and stuck in the vessel and the distal tip remained lodged in the vessel.It was further reported that when attempted to retrieve the wire, the distal tip still remained lodged in the vessel and did not allow the removal.Furthermore, with the distal tip lodged in the vessel, the wire that remained in the catheter was cut and a snare was inserted to remove the tip, but it was not retrievable.Reportedly, a catheter was inserted toward the wire tip site to separate the wire from the vessel wall, but was unsuccessful and finally, the remaining wire was pulled back by snaring its distal part again and the wire was removed successfully.However, although the wire was successfully removed, the peroneal blood flow was compromised due to vascular rupture.Apparently, post procedure, the patient developed wound infection and two weeks after the procedure, the patient reportedly expired.The cause of the death was due to multiorgan failure associated with sepsis.

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: 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 and images were provided for review.The investigation of the reported event is currently underway.H10: donghoon han, dong-geum shin, min-kyung kang, jung rae cho, et.Al (2021).Complications associated with the rotarex® wire in a patient with peripheral artery disease.Clinical case reports, 9(5):e03195.Doi: 10.1002/ccr3.3195.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.

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: manufacturing review: the batch number is unknown, therefore a manufacturing review can not be performed.Investigation summary: the physical sample was not returned for evaluation and hence, a physical investigation was not possible.The user provided information suggest guidewire break during intervention.The user provided images in the article show broken guidewire.The reported malfunction of guidewire break can be confirmed.The user also reported that patient expired, as it is stated in the report "post procedure, the patient developed wound infection and two weeks after the procedure, the patient reportedly expired.The cause of the death was due to multiorgan failure associated with sepsis." there was no rotarex caused patient expiration.The investigation is confirmed for the reported guidewire break issue.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: donghoon han, dong-geum shin, min-kyung kang, jung rae cho, et.Al (2021).Complications associated with the rotarex® wire in a patient with peripheral artery disease.Clinical case reports, 9(5):e03195.Doi: 10.1002/ccr3.3195.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 titled "complications associated with the rotarex wire in a patient with peripheral artery disease" that during a thrombectomy and atherectomy procedure in the superficial femoral artery, the distal wire tip allegedly got coiled and stuck in the vessel and the distal tip remained lodged in the vessel.It was further reported that when attempted to retrieve the wire, the distal tip still remained lodged in the vessel and did not allow the removal.Furthermore, with the distal tip lodged in the vessel, the wire that remained in the catheter was cut and a snare was inserted to remove the tip, but it was not retrievable.Reportedly, a catheter was inserted toward the wire tip site to separate the wire from the vessel wall, but was unsuccessful and finally, the remaining wire was pulled back by snaring its distal part again and the wire was removed successfully.However, although the wire was successfully removed, the peroneal blood flow was compromised due to vascular rupture.Apparently, post procedure, the patient developed wound infection and two weeks after the procedure, the patient reportedly expired.The cause of the death was due to multiorgan failure associated with sepsis.

• Brand Name: ROTAREX
• Type of Device: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18765181
• MDR Text Key: 336051538
• Report Number: 3008439199-2024-00027
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ROTAREX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• 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
• Patient Age: 87 YR
• Patient Sex: Male