MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80219

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.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 provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of 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 pending return.

Event Description

It was reported that during a recanalization procedure, while withdrawing the device, the patient allegedly complained of back pain and upon an angiogram, the guidewire was allegedly found to be detached.It was further reported that the detached guidewire was allegedly left inside the patient.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.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 for the catheter was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the guidewire angled was delivered for evaluation and physically investigated.During physical investigation, the guidewire was found broken 13 cm from its tip.The broken tip of the guidewire was not sent, the catheter was not sent for the investigating either.No further physical damage was found on the guidewire.Therefore, the investigation is confirmed for the reported guidewire break and detachment issue.A clear root cause could not be identified but a damaged guidewire represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2024).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.

Event Description

It was reported that during a recanalization procedure, while withdrawing the device, the patient allegedly complained of back pain and upon an angiogram, the guidewire was allegedly found to be detached.It was further reported that the detached guidewire was allegedly left inside the patient.The current status of the patient 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: 18273726
• MDR Text Key: 329828168
• Report Number: 3008439199-2023-00210
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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: 80219
• Device Lot Number: 222020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention