MAUDE Adverse Event Report: COVIDIEN (IRVINE) SILVERHAWK BTK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	P4044
Medical Device Problem Codes	Difficult to Remove (1528); Component or Accessory Incompatibility (2897); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Occlusion (1984); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician used one silverhawk to treat a non-tortuous and non-calcified lesion.The device was removed from its packaging and inspected with no issues noted.On attempting to remove the device, the non-mdt guidewire prolapsed between the nosecone and the sheath causing the device to become stuck.The physician made multiple attempts to remove the device, eventually causing the distal tip of the device to break off.The tip migrated down the peroneal of the patient resulting in an occluded peroneal artery.It was reported that no attempts were made to remove the detached tip and that the device fragment was left in the patient.No other patient injury was reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Device evaluation summary: the silverhawk device was returned, along with the detached cutter driver.The silverhawk was inspected and noted the distal clear end of the distal assembly was curved upwards.Dried blood was noted within the lumen of the laser drilled end.The rotating distal tip was not attached to the distal assembly.The tip was broken off from the laser drilled tip body.The silverhawk guidewire tubing was inspected and observed a zipper tear from the proximal end of the tubing, through to the end at the distal tip.No other damages to the returned device were noted.Attempts to back-load and front-load a 0.014" guidewire from the lab were unsuccessful due the zipper tearing.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6676769
• Report Number: 2183870-2017-00280
• Device Sequence Number: 1971290
• Product Code: MCW
• UDI-Device Identifier: 00821684074107
• UDI-Public: 00821684074107
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 08/28/2017

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: 12/13/2018
• Device Catalogue Number: P4044
• Device Lot Number: A388883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 06/02/2017; 08/28/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 09/07/2017; 09/26/2017
• 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: Other
• Patient Age: 68 YR
• Patient Weight: 136