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

Model Number AB14W060060150

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2022

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 elite pta balloon during procedure to treat a severely calcified lesion in the mid superficial femoral artery (sfa) with chronic total occlusion (cto-100%).The vessel was moderately tortuous.The vessel diameter was 6mm.A non-medtronic inflation balloon was used for balloon inflation.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepper per ifu with no issues identified.It was reported that balloon burst/leak/rupture occurred during inflation at 7atm.All fragments of the balloon were retrieved.The device passed through a previously deployed stent.There was no resistance encountered when advancing the device.It was reported that physician snared two pieces of the broken balloon out of the body.The balloon ruptured after the second inflation inside of a stent.Everflex stent was used.No further patient injury reported.

Manufacturer Narrative

Additional information: there was no vessel damage.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

Image analysis: the customer returned 2 images.Image 1 shows the product shelf carton, which confirms the size 6.0x60 and the lot number: a861527 and the device coiled in a biohazard bag positioned on top of the shelf carton.Image 2 shows a close-up picture of a portion of the device through the biohazard bag.Product analysis: the balloon and a part of the guidewire lumen returned detached.A visual inspection of the device shows that the balloon burst in length and the guidewire lumen has been stretched.1 marker band was present on the guidewire lumen.No functional testing could be carried out.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.

• 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: 13470409
• MDR Text Key: 285160364
• Report Number: 2183870-2022-00043
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110420
• UDI-Public: 00763000110420
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: AB14W060060150
• Device Catalogue Number: AB14W060060150
• Device Lot Number: A861527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• 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