MAUDE Adverse Event Report: MEDTRONIC IRELAND BTK TURBOHAWK; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	THS-SS-CL
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Compatibility Problem (2960); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a turbohawk directional atherectomy along with a non medtronic 6fr sheath and a medtronic 0.014 guide wire in procedure to treat a little calcified plaque lesion in the left proximal posterior tibial artery with 90% stenosis.The vessel is moderately tortuous.The vessel diameter and lesion length are 3 mm and 80 mm respectively.The vessel was not pre dilated but post dilated.The ifu was followed during preparation, procedure and post procedure.During withdrawal there was moderate resistance felt and tip damaged, the tip broke where it was twisted for cleaning.It was reported that after atherectomy was performed in the left pta and the device was being removed, physician noticed resistance with the device with entering the 6fr crossover sheath.Physician noticed a prolapse in the.014 nitrex guide wire.After straightening the wire, device entered the sheath.Upon removal of the device, it was noticed that the tip of the nosecone was not present on the device.Physician looked at the end of the sheath under the magnified fluoroscopy and saw the tip still on the wire.There was a stenosis that was going to be stented during procedure, physician decided to stent the tip to the wall in the external iliac artery.An angioplasty of the lesion in the left pta that previously had atherectomy performed on.Subsequently, arteriography showed inline flow to the foot.
Additional Manufacturer Narrative
Product analysis: the turbohawk device was returned to the medtronic investigation lab for analysis.No ancillary devices or images were returned with the device.Cutter driver not returned.Biological debris throughout housing.Rotating distal tip detached but not returned.Tecothane remains intact.Bend noted in the housing from the proximal end to distal end.Microscopic inspection revealed substance consistent with dried blood covering the cutter window.Dried blood was removed for inspection.It was noted the cutter was returned just distal to the cutter window.Inspection of the guide wire lumen revealed the proximal end of the lumen was torn proximally.Zipper tearing was observed throughout the remainder of the housing lumen.No anomalies were observed with the rotating distal tip joint.The returned device was connected to a cutter driver from the lab.Retracted the cutter into the cutter window.Biological debris and contrast were noted on the cutter; no further anomalies were noted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: three passes were performed with the turbohawk.The cutter was inside the housing when the device was removed from the patient.The tip of the turbohawk was stented to the external iliac artery using a visipro balloon expandable stent.Angioplasty was carried out using a chocolate balloon on the lesion in the left posterior tibial artery, that previously had atherectomy performed on.Patient is in a stable condition and has been discharged from the hospital.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BTK TURBOHAWK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9383458
• Report Number: 9612164-2019-04927
• Device Sequence Number: 11363535
• Product Code: MCW
• UDI-Device Identifier: 00643169968202
• UDI-Public: 00643169968202
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2021
• Device Model Number: THS-SS-CL
• Device Catalogue Number: THS-SS-CL
• Device Lot Number: 0009413209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 12/03/2019; 02/14/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 11/28/2019; 12/04/2019; 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention