MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80219

Device Problem Break (1069)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that during a recanalization procedure via left femoral, the guidewire was allegedly broken.It was further reported that the guidewire breaks causing perforation of the vessel and leaving a portion of the guidewire inside the artery.Reportedly, the specialist decides to schedule the patient for surgery to treat the chronic occlusion of the artery and for the extraction of the foreign body.The current status of the patient is unknown.

Manufacturer Narrative

The catalog number identified 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.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.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.However, an image and photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 07/2024).Device pending return.

Event Description

It was reported that during a recanalization procedure via left femoral, the guidewire was allegedly broken.It was further reported that the guidewire breaks causing perforation of the vessel and leaving a portion of the guidewire inside the artery.Reportedly, the specialist decides to schedule the patient for surgery to treat the chronic occlusion of the artery and for the extraction of the foreign body.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 physical sample was returned for evaluation.A catheter and the guidewire were physically investigated.The flexible tip of the guidewire was decoiled.The catheter was full of coagulated material, but after flushing nominal aspiration level was achieved.The user provided images were reviewed and it can be confirmed the guidewire damage.A clear root cause could not be identified based upon the available information but a damaged guidewire represents a known inherent risk.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 (expiration date: 07/2024).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.

• 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: 15308941
• MDR Text Key: 298774882
• Report Number: 3008439199-2022-00112
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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: 211747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 62 KG