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

Catalog Number THS-SX-C

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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.

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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9071053
• MDR Text Key: 158693935
• Report Number: 9612164-2019-03942
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968226
• UDI-Public: 00643169968226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 09/23/2019; 10/01/2019; 12/09/2019
• Supplement Dates FDA Received: 09/25/2019; 10/17/2019; 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2019
• 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: 81 YR