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

Catalog Number	THS-SX-C
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2019
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 was attempting to use a turbohawk atherectomy along with non medtronic 6fr sheath and guide wire to treat a little calcified lesion in the common iliac artery.The vessel is severely tortuous with a diameter of 7mm.The vessel was pre dilated but not post dilated.Ifu was followed during preparation, procedure and post procedure.It was reported that during withdrawal, minimal resistance was encountered and the tip separated at hinge pin (nose cone).There was no guide wire prolapse.It was reported that the nose cone was completely removed from the shaft of the catheter.The nose cone was stented (caged) into the iliac artery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the location of the pins is unknown.A visipro stent was used to cage the nose cone.Patient is not scheduled for additional intervention.Patient is doing well.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation the turbohawk device and cutter driver were removed from the return packaging for inspection.The turbohawk was connected to the cutter driver.A bend was noted in the torque shaft beneath the strain relief.It was observed the distal assembly was fractured apart.The distal housing, including coiled segment and rotating distal tip, was not returned for evaluation.A radial fracture was observed between the anchor pockets and proximal end of the coiled segment of the housing.The cutter was advanced approximately 2.8cm distal from the cutter window.Microscopic inspection revealed suspected pet wrapped around the proximal end of the cutter head.The distal edge of the cutter window housing and a proximal portion of the inner laser drilled coil showed signs of damaged and jagged edges.No damage was noted to the cutter window.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: 9071053
• Report Number: 9612164-2019-03942
• Device Sequence Number: 1984552
• Product Code: MCW
• UDI-Device Identifier: 00643169968226
• UDI-Public: 00643169968226
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/11/2019

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: 07/03/2022
• Device Catalogue Number: THS-SX-C
• Device Lot Number: 0009815592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/23/2019; 10/01/2019; 12/09/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 09/25/2019; 10/17/2019; 12/11/2019
• 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
• Patient Age: 81 YR