MAUDE Adverse Event Report: COVIDIEN (IRVINE) HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	07/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cine images analysis summary: the hawkone directional atherectomy device was not received for evaluation.A disc containing 12 cine folders was received and reviewed.The first two files depict angioplasty of a stented iliac artery.The third and fourth files depict contrast flow through the targeted vessel anatomy prior to treatment.In the fifth file, the flow through the targeted vessel anatomy has improved.The sixth file the flow through the targeted vessel anatomy has improved and arterial vessel gain is observed in the proximal end of the targeted vessel.The seventh file the flow through the targeted vessel anatomy has improved and arterial vessel gain is larger in the targeted vessel.The eighth file shows balloon angioplasty in the targeted vessel and extends distally through a previously implanted stent.The ninth and tenth files depicts contrast flow through the treated vessel after directional atherectomy and angioplasty.The vessel exhibits increased arterial vessel gain.The eleventh file depicts contrast flow distally in the lower limb after treatment.The twelfth file depicts contrast flow at the injection site.The arterial vessel gain of the treated section is larger in diameter than the angioplasty balloon used in the treatment.This enlarged vessel gain is most likely the pseudo aneurysm claimed in the initial reported event.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 or Problem Description
Physician used a hawkone directional atherectomy device with a 7 fr sheath and 7 mm embolic protection device for the treatment of a 100 mm moderately calcified lesion in the proximal left sfa of diameter 5-6 mm.Lesion exhibited chronic total occlusion (cto).Ifu was followed.Procedure completed as normal.It was reported that atherectomy with post dilation showed good result with slight appearing pseudo aneurysm.During the recovery period, patient reported increased groin pain; ultrasound showed an increase in the size of pseudoaneurysm; therefore, the patient was sent to hospital.Patient was admitted to the hospital and monitored for pain and any further possible issues.Patient was also treated with a non-medtronic stent (7 mm x 5 cm/8 mm x 5 cm) to cover the lesion.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6802749
• Report Number: 2183870-2017-00350
• Device Sequence Number: 1853088
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• 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): 07/19/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A296513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/17/2017
• 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: Hospitalization
• Patient Age: 77 YR
• Patient Weight: 57