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

Model Number	AB14W060060150
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
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 was attempting to use a nanocross pta balloon during procedure to treat the superficial femoral artery (sfa).A non-medtronic inflation device was used for balloon inflation.The device was prepped per ifu with no issues identified.It was reported that during balloon inflation, burst/leak/catheter leak was noted at 8am.All balloon fragments were retrieved from patient.There was no patient injury reported.
Additional Manufacturer Narrative
Product analysis visual inspection: the device was removed from the return packaging.The balloon was in a post-inflation state.A red, blood-like substance was observed within the balloon assembly manifold indicated size 6.0x60mm functional testing: a 0.014¿ guidewire was loaded with ease through the distal tip of the catheter and navigated out the proximal hub of the manifold.A 20cc syringe with a manometer was attached to the inflation lumen leur lock of the manifold.The balloon chamber was attempted to be inflated; however, the balloon was unable to maintain pressure.A longitudinal tear was observed along the balloon was approximately 2.8cm in length.Microscopic inspection: both the proximal and distal bonds on the balloon were intact.Both the proximal and distal marker bands were identified 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
Additional information: negative prep was performed.A balloon leak occurred.The device did ot fragment and it was safely removed from the patient.There was no vessel damage noted.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: 10464585
• Report Number: 2183870-2020-00273
• Device Sequence Number: 3177454
• Product Code: LIT
• UDI-Device Identifier: 00763000110420
• UDI-Public: 00763000110420
• 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): 11/03/2020

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: 02/11/2023
• Device Model Number: AB14W060060150
• Device Catalogue Number: AB14W060060150
• Device Lot Number: A975090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 09/09/2020; 11/02/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/11/2020; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1