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

Model Number	AB14W050200150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
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 with a 6fr non-medtronic sheath and 7mm spider fx device during treatment of a 150mm fibrous lesion in the patient¿s mid right superficial femoral artery (sfa) of diameter 6mm.The vessel is described as being non-tortuous and slightly calcified.Lesion exhibited 80% stenosis.Pre-dilation was performed using the nanocross elite.The balloon was inflated with a contrast/saline mix using a non-medtronic inflation device.The balloon was removed and a non-medtronic stent was placed.The nanocross balloon was reinserted to post-dilate.The balloon inflated as normal but would not deflate.After multiple reinflations and deflations, and utilizing a large syringe on the stop cock, the balloon was deflated successfully and removed.Total deflation time reported as 240 seconds.A new balloon was used to complete the procedure.No injury reported.
Additional Manufacturer Narrative
Additional information: the balloon was inflated to nominal pressure during pre and post dilation.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.
Additional Manufacturer Narrative
Product analysis: the nanocross elite was returned inside a previously opened nanocross elite box and pouch, which both indicated lot a862913.No ancillary devices were included.The nanocross elite was inspected and observed it was in a post-inflated state.No damages to the manifold assembly or catheter shaft was noted.The balloon segment showed areas of twisting of the balloon at approximately 4cm, 10cm, and 16cm.It should be noted twisting of the balloon material was observed at the proximal end of the balloon segment.The strain relief of the catheter shaft was removed and found no damages that would appear to have contributed to deflation difficulty.It should be noted the proximal balloon bond was inspected under microscope and found no damages or anomalies that would appear to have contributed to deflation difficulty.A 0.014" was unable to be loaded the catheter and could not be flushed likely due to a blockage introduced post procedural.The balloon was successfully inflated with water at 8 atm and was able to maintain pressure.The balloon was then deflated with no observed blockage from the catheter.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: 9213339
• Report Number: 2183870-2019-00512
• Device Sequence Number: 13539055
• Product Code: LIT
• UDI-Device Identifier: 00763000110369
• UDI-Public: 00763000110369
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132777
• 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): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: AB14W050200150
• Device Catalogue Number: AB14W050200150
• Device Lot Number: A862913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 01/27/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/05/2019; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 161