MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	AB35W05040080
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/29/2017
Type of Reportable Event	Death
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.
Event or Problem Description
Physician used an evercross pta balloon with a 6 f sheath and.035 guidewire for the treatment of a moderately tortuous, severely calcified 40mm lesion in the right proximal superficial femoral artery of diameter 6mm which exhibited cto (chronic total occlusion).Embolic protection was not used.The device ifu was followed and no issues noted during prep.The balloon was inflated using an inflation device (inflation fluid unknown) to a pressure of 10atms.The device did not pass through a previously deployed sent.There was resistance encountered when advancing the device and excessive force was used during delivery.It was reported that after inflation, the balloon became stuck in the patient¿s leg.When physician tried to retrieve it, the patient developed a leak at the base of her aorta (balloon was fully deflated for removal).Patient was transferred to the operating room for femoral endarterectomy following several attempts at removing the balloon.The patient died days later after the procedure in the icu.Physician reported the cause of death is severe peripheral vascular disease (pvd).

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6749437
• Report Number: 2183870-2017-00319
• Device Sequence Number: 187597
• Product Code: LIT
• UDI-Device Identifier: 00821684061381
• UDI-Public: 00821684061381
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• 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): 06/29/2017

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: 04/16/2018
• Device Catalogue Number: AB35W05040080
• Device Lot Number: A091264
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/27/2017
• 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: Death
• Patient Age: 84 YR
• Patient Weight: 63