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

Model Number AB14W060120150

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a physician was attempting to use a nanocross elite pta balloon catheter to treat a prox/mid superficial femoral artery lesion in the in a patient with plaque, little tortuosity, and moderate calcification.A non-medtronic inflation device and a non-medtronic guidewire was used.No issues noted when removing the device from the hoop/tray, damage noted to packaging.Device was prepped as per ifu with no issues noted.It was reported that removal difficulties occurred removing balloon following balloon inflation.The device passed through a previously deployed stent, no resistance encountered when advancing the device, excessive force was not used.A stent was placed in the sfa.A 6x120 nanocross balloon was inflated to post dilate the stent.The physician went to 16atm, which is past rbp and the balloon burst.When trying to retrieve the burst balloon, the balloon must have got caught on something and the balloon portion peeled off of the catheter, and the distal end of the catheter snapped off.The portion of the balloon that got stuck in the stent was unable to be retrieved.The physician could not advance a wire past the balloon when it came off of the catheter and could not be retrieved.The vessel is occluded by the balloon and procedure was ended because there was nothing else they could do to try and remove it.No further patient injury reported for this event.

Manufacturer Narrative

Additional information: physician reported that a bypass surgery would likely be needed due to the balloon blockage in the sfa.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

Product analysis the device was returned with the distal end the inner and the balloon detached, (photos 8 & 9).The detached components were not returned.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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14546062
• MDR Text Key: 293446741
• Report Number: 2183870-2022-00187
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110482
• UDI-Public: 00763000110482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB14W060120150
• Device Catalogue Number: AB14W060120150
• Device Lot Number: B312348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female