MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY

Model Number H1-LS

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problem Vascular Dissection (3160)

Event Date 12/10/2021

Event Type  Injury  

Event Description

Physician was attempting to use a hawkone atherectomy device to treat a little tortuous, little calcified, plaque lesion within the mid superficial femoral artery. Device prepped per ifu with no issues identified. It was reported that device was caught on a stent strut and was pinched. Device wouldn't come free so they called rep who talked them through getting the device free from the stent. Nosecone separated from catheter. No intervention was required for tip removal. It was trapped by the spider and removed with the sheath. The stent was damaged. Pieces of the stent were inside the nose cone. The vessel had a small dissection. The procedure was completed by accessing ipsilateral and placing another stent. No other complications were reported. There was no damage to the spiderfx device and the damaged stent was not a medtronic stent. No patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Physician was attempting to use a hawkone atherectomy device to treat a little tortuous, little calcified, plaque lesion within the mid superficial femoral artery. Device prepped per ifu with no issues identified. It was reported that device was caught on a stent strut and was pinched. Device wouldn't come free so they called rep who talked them through getting the device free from the stent. Nosecone separated from catheter. No intervention was required for tip removal. It was trapped by the spider and removed with the sheath. The stent was damaged. Pieces of the stent were inside the nose cone. The vessel had a small dissection. The procedure was completed by accessing ipsilateral and placing another stent. No other complications were reported. There was no damage to the spiderfx device and the damaged stent was not a medtronic stent. No patient injury reported.

• Brand Name: HAWKONE 7F
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13167189
• MDR Text Key: 286114623
• Report Number: 9612164-2022-00032
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: H1-LS
• Device Catalogue Number: H1-LS
• Device Lot Number: 0010619806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 01/05/2022 Patient Sequence Number: 1