MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

Model Number SPD2-US-040-190

Device Problem Looping (1370)

Patient Problem Perforation of Vessels (2135)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: a spider fx and turbohawk were received for analysis.The spider was not loaded into the turbohawk.A cutter driver was connected to the turbohawk.The spider fx capture wire was inspected and observed the distal rotating tip loaded behind the filter assembly.Traces of biological debris was noted within the filter basket.Approximately 75 cm from the distal tip a bend/loop to the capture wire was discovered.No traces of wear to the ptfe coating was noted.Analysis summary/results: the tip detached from the distal assembly of the turbohawk during withdrawal.The wire the turbohawk was loaded was a spider fx capture wire.A loop/bend to the capture wire was noted and the tip of the turbohawk remained loaded on the wire.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was using a turbohawk device to perform an atherectomy procedure in the left popliteal/tibial region.Embolic protection was used during the procedure.It was reported that after performing three passes, a slight resistance was felt while removing the device from the artery.The nosecone tip of the turbohawk detached; however, it remained on the wire due to the embolic protection device.The entire system was removed successfully.It was suspected that pulling the device back may have caused an injury to the vessel wall, thus the lesion was stented after obtaining a retrograde access from the anterior tibial artery to pass a new guidewire through the lesion.Patient¿s condition was reported to be stable with baseline pulses intact.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6492393
• MDR Text Key: 72781245
• Report Number: 2183870-2017-00169
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111010
• 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
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPD2-US-040-190
• Device Catalogue Number: SPD2-US-040-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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