MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Model Number VERSION 1.0

Device Problems Retraction Problem (1536); Mechanical Jam (2983)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/28/2022

Event Type  Injury  

Event Description

It was reported that during a recanalization procedure, the device was allegedly clutched out about halfway.It was further reported that device allegedly unable to remove thorough sheath and removed together as unit.Reportedly outer covering was peeled back and slight dissection of the vessel.Additionally new stent was placed to repair the dissection, which was successful.The patient is stable now.

Manufacturer Narrative

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, photos were provided for review.The investigation of the reported event is currently underway.Expiry date: 07/2024.

Event Description

It was reported that during a recanalization procedure, the devicer was allegedly clutched out about halfway.It was further reported that device allegedly unable to remove thorough sheath and removed together as unit.Reportedly outer covering was peeled back and slight dissection of the vessel.Additionally new stent was placed to repair the dissection, which was successful.The patient is stable now.

Manufacturer Narrative

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 returned for evaluation.The catheter was pointing 35 mm out of the sheath.The transparent part of the tube was completely melted and blocking the helix.The catheter was stuck inside the sheath, probably also due to overheating and melting.It is assumed the catheter ran without sufficient flow and therefore had heat development.A definite root cause could not be determined based upon the available information.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: 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: 14157105
• MDR Text Key: 289608331
• Report Number: 3008439199-2022-00044
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: (01)07640142810582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211738
• 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
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSION 1.0
• Device Catalogue Number: 80237
• Device Lot Number: 211880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• 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: 82 YR
• Patient Sex: Female