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

Catalog Number P4028

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

The silverhawk was returned for evaluation.No ancillary devices were included.The silverhawk was inspected.The distal tip of the silverhawk was buckled/compressed.Within the distal tip of the silverhawk and a green material was observed which could not be removed without potentially damaging the tip of the device.The material is not from the silverhawk as the components of the silverhawk do not match the characteristics of the debris observed with the tip.It is unknown if the green material is from the outer jacket of the guidewire used during the procedure or may have been introduced post-procedure.It should be noted the distal tip of the silverhawk has a rounded/blunt tip, but the tip appears as though it may have been subjected to friction and/or compression.The torque shaft guidewire tubing showed a longitudinal zipper tear throughout the segment.No other damages or anomalies to the returned silverhawk were noted.Functional testing was completed and a 0.14" guidewire from the lab was front loaded the distal assembly.The guidewire could not be loaded through the torque shaft guidewire lumen due to the zipper tear.The outer diameter was measured using a digital snap gauge with no issues identified.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a hawkone and a silverhawk to treat a severely calcified lesion with 75-90% stenosis in the right mid proximal tibial popliteal trunk.Artery diameter and lesion length were 3mm and 40mm respectively.Physician used a cook 6fr 90cm sheath and a cook hydro 014x300.Ifu was followed and the device was prepped without issue.Vessel was pre and post dilated.The h1-s would not cross.The vessel was pre-dilated with a nano 2x80 device at 8atm for 1minute.The h1-s was attempted again but it would not cross the lesion.Pre-dilated again with the same nano device at 14 atm for 1.5 min.Physician then attempted to use a silverhawk.This device crossed the proximal lesion upon third advancement, but did not cross mid or distal lesion and upon removal scrub technician noticed an irregularity in the clear housing tip.The tip of the silverhawk was reported to feel ridged and looked irregular to the technician.It was removed safely and intact <(>&<)> without difficulty.There was no deformity noted with the cutter.Physician then chose to use a 0.9 laser forward pass at 45/45 and reverse pass at 45/60 angiogram but was still not acceptable.Thus, the physician decided to use a mdt drug eluting coronary resolute stent with successful results.No patient injury was reported.

• Brand Name: SILVERHAWK BTK
• 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: 8145801
• MDR Text Key: 129750145
• Report Number: 9612164-2018-03520
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968455
• UDI-Public: 00643169968455
• 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: Physician
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Catalogue Number: P4028
• Device Lot Number: 0009304005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Date Device Manufactured: 08/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 95