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

Catalog Number	P4052
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Occlusion (1984); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a silverhawk with a non-mdt 7 fr sheath and non-mdt 0.014 guidewire for the treatment of a slightly calcified cto (chronic total occlusion-100%) plaque lesion in the left proximal superficial femoral artery (sfa).The device was prepped as per ifu.The vessel was not pre or post dilated.The vessel was reported to be slightly tortuous.It is reported that moderate resistance was experienced during withdrawal.The tip separated at the hinge pin and the nosecone twisted off.The patient went for surgery to remove the detached portion which had occluded the vessel.The patient is reported to be fine.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7333513
• Report Number: 2183870-2018-00138
• Device Sequence Number: 13594991
• Product Code: MCW
• UDI-Device Identifier: 00821684074121
• UDI-Public: 00821684074121
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2018
• Device Catalogue Number: P4052
• Device Lot Number: A338496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70