MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80219

Device Problems Crack (1135); Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

The fda rn number and manufacturing location for the straub product was selected as (b)(4) and unknown due to system limitations.The correct fda rn number and manufacturing location are 3008439199 and straub medical us.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that during a procedure to treat thrombosis in the sfa and popliteal artery and after aspiration, no blood flow was noted.The device was reported to be withdrawn and no liquid was noted to be flowing out when flushing it.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a procedure to treat thrombosis in the sfa and popliteal artery, and after aspiration, no blood flow was noted.The device was reported to be withdrawn and no liquid was noted to be flowing out when flushing it.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the fda rn number and manufacturing location for the straub product was selected as 2020394 and unknown due to system limitations.The correct fda rn number and manufacturing location are 3008439199 and 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.It was observed that thrombotic and calcified material accumulated inside the handle and was blocking the rotation of the gear wheals.The magnet of the clutch had cracks and parts of the magnet broke off and got stuck in the bearing and gear wheels.The main problem was the destruction of the bearing with the cracked material from the magnet.This incident occurred due a material problem.Therefore, the investigation confirmed for the reported issues.The definitive root cause could not be determined based upon 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: g3, h6 (device) h11: h6 (method, result, conclusion) 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): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11782651
• MDR Text Key: 249272600
• Report Number: 2020394-2021-00986
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80219
• Device Lot Number: 201288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 65