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

Model Number AB14W060040150

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/14/2021

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 nanocross pta balloon along with non-medtronic 6fr sheath and 0.014" guidewire during procedure to treat a severely calcified lesion on the proximal, mid and distal superficial femoral artery (sfa) with 80-90% stenosis.The vessel was moderately tortuous.The vessel diameter and lesion length are 6-7mm and 30mm respectively.No embolic protection was used.Inflation device was used for balloon inflation.Hep saline was used for inflation fluid.There was no damage noted to packaging.There was no issue noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues identified.During single inflation, balloon burst occurred at 12atm.All fragments of the balloon were retrieved.The balloon did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.During withdrawal excessive force was used.Physician aborted case after balloon remained partially in the body to be removed.Patient was ok post op no events related to the procedure.It was reported that contralateral access was used when treating a 80-90% stenotic right common femoral artery using atherectomy thx-svc followed by angioplasty of the sfa using a nanocross 6x40x150 which burst before rated pressure.In the process of trying to remove the balloon catheter physician was able to pull into the non-medtronic 6f sheath, where it got stuck.Struggling to remove it physician tried pulling as one unit (6f sheath, 0.014 wire, and the balloon catheter) with no success.Balloon detached from the catheter was able to remove everything but the actual balloon which remained inside of the left common femoral artery.Losing all access, balloon still in the artery, physician needed to do a cut down, opened up the artery in order to remove the foreign body.Everything went well, patient was safely removed from the ir and went home no complications or any other related events.

Manufacturer Narrative

Device evaluation the balloon detached at approx.5cm proximal to the distal tip and the remainder of the balloon material and inner lumen was not received.Under a microscope the detachment site and tear is noted along the balloon material.A tear is noted just proximal to the distal tip.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, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12017124
• MDR Text Key: 256777781
• Report Number: 2183870-2021-00214
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110406
• UDI-Public: 00763000110406
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB14W060040150
• Device Catalogue Number: AB14W060040150
• Device Lot Number: B195137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 77