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

Model Number AB14W030210150

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a hawkone atherectomy device and nanocross pta balloon during treatment of a plaque lesion in the patient¿s mid and distal posterior tibial artery, anterior tibial artery, and peroneal artery.Moderate vessel calcification and tortuosity are reported.Lesion exhibited 80% stenosis.A 6fr non-medtronic sheath and 0.014 non-medtronic guidewire were used.Ifu was followed and the hawkone device was prepped without issue.The guidewire was hydrated at prep.The device was advanced over the bifurcation.No resistance was noted during advancement of the device.It is reported that the device locked up on the wire and could not be removed over it.The hawkone and wire were removed in tandem.Following this a nanocross pta balloon was used for treatment.There was no damage noted to the product packaging.The device was removed from the packaging without issue.The device was prepped as per ifu without issue.A non-medtronic inflation device was used for balloon inflation.The device was not passed through a previously deployed stent.No resistance was noted during advancement of the device.Following inflation at the target site, the balloon would not deflate.The physician pulled the balloon out inflated but it would not come through the sheath and detached from the catheter.A snare was used to remove the detached portion.The procedure was successful.No patient injury reported.

Manufacturer Narrative

Additional information: there was no damage noted to the hawkone.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.

Manufacturer Narrative

Additional information: all parts of the nanocross balloon were removed from the patient.No vessel damage was noted.There was no other intervention required for removal.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.

Manufacturer Narrative

Device evaluation a non-medtronic 0.014¿ guidewire returned loaded inside the luer of the device and was unable to be removed due to resistance.Using a micrometer, the guidewire inside the device was confirmed to be a 0.014¿ guidewire and measured approximately 300cm in length.A detached balloon portion returned in the same packaging.The balloon was returned in a post inflated state with excessive stretching visible on the inner lumen.Visual inspection of the catheter shaft with the strain relief removed, indicated damage of the inner guidewire lumen, possibly due to dried contrast inside the gw lumen.This may have contributed to the guidewire becoming stuck inside the catheter shaft and unable to be removed however this cannot be confirmed.Measurement from distal end of strain relief to detached site is approximately 135.2cm.Measurement from distal tip of catheter to detached site is approximately 32.5cm.Distal marker band visible and intact.Bunching visible on distal balloon chamber.Twist on catheter inner lumen approximately 82cm proximal to the distal end of strain relief.The non-medtronic guidewire is visible under a microscope inside the catheter shaft ending at approximately 125.3cm distal from the distal end of the strain relief.The inner lumen detachment site is visible at approximately 115cm distal from the distal end if strain relief.Excessive stretching on the inner and outer catheter lumens makes the measurement hard to estimate.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 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: 10904323
• MDR Text Key: 218253590
• Report Number: 2183870-2020-00395
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000109882
• UDI-Public: 00763000109882
• Combination Product (y/n): N
• PMA/PMN Number: K082854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: AB14W030210150
• Device Catalogue Number: AB14W030210150
• Device Lot Number: B097429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention