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

Model Number AB14W050060150

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a nanocross pta balloon along with 7fr sheath and non-medtronic 0.014" guidewire during procedure to treat a little calcified plaque lesion in the left distal superficial femoral artery (sfa) with 90% stenosis.The vessel was little tortuous.The vessel diameter and lesion length are 5mm and 80mm respectively.A non-medtronic indeflator was used for balloon inflation.A 50/50 saline and contrast used for inflation fluid.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.Balloon deflation difficulties occurred; the device would not deflate at the lesion site.The deflation issue was noted during subsequent inflation and then there was difficulty removing balloon following inflation.The device passed through a previously deployed stent.No resistance encountered when advancing the device.The balloon was inflated to 8 atm for procedural purposes.The physician also attempted to inflate the balloon beyond the rated burst pressure in an attempt to rupture the balloon and remove it from the patient.The physician doesn¿t remember the exact atmospheric pressure that he reached in that attempt.There was no visible vessel damage noted via angiography.It took roughly 10 minutes to remove the balloon from the patient.The balloon was pulled back to the sheath still inflated.The pressure of the sheath pushed the contrast back toward the hub of the balloon until it was deflated enough to pull through the sheath.The balloon was inflated and deflated outside of the body, and slow deflation times were still noted.There was no patient injury.

Manufacturer Narrative

Product analysis: the nanocross elite device was returned to medtronic investigation lab for analysis.The device was returned coiled in a biohazard bag.No ancillary devices were included.The strain relief was removed to inspect for damage at the proximal end of the catheter shaft, a kink is visible 2.4 cm distal to luer manifold.Visual inspection confirmed post deflated balloon profile as received.Under a microscope, crimping marks were noted on the proximal balloon bond chamber.No other deformation was noted on the device.A 10ml syringe was filled with water and connected to the guidewire port and flushed the device with no issues noted.A 0.014inch guidewire from the lab was loaded via the distal tip with no resistance.The device passed negative prep.The balloon was inflated to nominal pressure (8atm) and inflated to rbp (14atm) with no issues noted.The balloon failed to deflate after 3 minutes.The balloon remains in an inflated state.Image review: three cine images were returned for review.The first image shows a contrast flow injection of the targeted vessel anatomy showing the calcified lesions that may be 100% cto.The second image is of the targeted lesion prior to stent deployment with a guidewire running through the vessel.The third image shows an inflated pta device just above the knee post inflation of a deployed stent.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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11036247
• MDR Text Key: 222365556
• Report Number: 2183870-2020-00444
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110260
• UDI-Public: 00763000110260
• Combination Product (y/n): N
• PMA/PMN Number: K132777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: AB14W050060150
• Device Catalogue Number: AB14W050060150
• Device Lot Number: B105723
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 73