MAUDE Adverse Event Report: COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	AB14W050040150
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/02/2020
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
Physician intended to use a nanocross elite pta balloon with a non-medtronic 7fr sheath and non-medtronic guidewire during treatment of a 40mm plaque lesion in the patient¿s proximal left superficial femoral artery (sfa).Artery diameter reported as 9mm.Slight vessel calcification and tortuosity are reported.No damage was noted to the product packaging prior to sue.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.Following use of the balloon, it is reported that excessive force was used during withdrawal of the device as the physician felt resistance at the sheath and tugged.This resulted in a detachment at the tip with part of the balloon remaining in the sheath.The fragment dislodged at the access site as everything was removed.Access was gained on the opposite side and a snare was used for removal of the detached portion.No further injury reported.
Additional Manufacturer Narrative
Device evaluation the nanocross elite catheter was received in two segments.The proximal segment consisting of the y-manifold, catheter, and inner guidewire lumen.The distal segment consisting of the balloon chamber and distal tip.An inventory of the nanocross elite components revealed that the two radiopaque marker bands were not returned with the device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10815678
• Report Number: 2183870-2020-00379
• Device Sequence Number: 14474811
• Product Code: LIT
• UDI-Device Identifier: 00763000110246
• UDI-Public: 00763000110246
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 08/17/2023
• Device Model Number: AB14W050040150
• Device Catalogue Number: AB14W050040150
• Device Lot Number: B071112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 03/18/2021
• 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