MAUDE Adverse Event Report: COVIDIEN SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number P4052

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician intended to use the silverhawk with a 7f non-medtronic sheath and a spider fx 6mm, to treat a 150mm soft tissue lesion with 80-90% stenosis in the superficial and popliteal artery. Artery diameter 5mm. The device was inspected and prepped as per ifu with no issues noted. The vessel was not pre-dilated and no resistance was encountered. It was reported the tip of the silverhawk became damaged but did not completely detach. This occurred where the shaft meets the cutter. The physician opened a second silverhawk device. It was reported that the thumb switch was sticking and could not be pushed all the way forward. It is unknown if the cutter returned to the housing for removal of the device, but it was removed safely. The physician completed the procedure with the second device. No deformation was noted in the cutter when removed. No patient injury reported.

Manufacturer Narrative

Additional information: email address product analysis: two silverhawk units were returned. The second unit had a cutter driver attached. No other ancillary devices were included. During visual inspection, biological debris was observed within the lumen of the housing assembly. The cutter was positioned 0. 3cm distal the cutter window and the plunger was located approximately 0. 6cm from the cutter window. A bend to the distal assembly housing was identified approximately 0. 2cm from the cutter window. Functional testing was completed and the thumb switch was retracted with the cutter driver powered on. The cutter driver activated and the cutter driver retracted back into the cutter window as intended. The thumb switch was advanced, but stopped at 0. 3cm distal the cutter window. The silverhawk was soaked in water for approximately 24 hours and flushed using a distal flush tool from the lab. An attempt was made to advance the thumb switch but the cutter stopped at approximately 0. 3cm distal the cutter window. If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK ATK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8127926
• MDR Text Key: 129451939
• Report Number: 2183870-2018-00558
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/22/2018
• Device Catalogue Number: P4052
• Device Lot Number: A379918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage