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

Model Number	AB14W040150150
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Physician attempted to use a nanocross elite pta balloon with a 5fr non-medtronic (cook) sheath and a.014 non-medtronic (ashai gladius) guidewire during treatment of a 150mm calcified lesion in the patients left distal superficial femoral artery (sfa).Severe vessel tortuosity and severe vessel calcification were reported.Lesion exhibited 80% stenosis.Artery diameter reported as 6mm.There were abnormalities reported in relation to anatomy.Tortuous iliac bifurcation with significant disease and calcification made it difficult to track sheath up and over.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.No issues were noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.The vessel was not pre or post dilated.An inflation device was used.50/50 contrast inflation fluid was used.The device was not passed through a previously deployed stent.No resistance was noted during advancement of the device.A balloon burst was reported on first inflation at 8atms during procedure.Deflation difficulties were also reported.The balloon would not fully deflate and could not be rewrapped to fit back through the 5f sheath.The balloon portion of the catheter separated from the shaft when physician and tech attempted to walk it off the wire.The balloon eventually deflated when a snare was used to retrieve detached balloon.An additional nanocross elite pta balloon was used with a buddy wire to attempt fully deflate the popped balloon and this balloon also got stuck and detached.The second balloon detached within the sheath and was removed with a sheath exchange.The devices were safely removed from the patient.Procedure was aborted.Stenting was not completed and patient will return for another procedure to complete stenting portion of the intervention.No patient injury reported.
Additional Manufacturer Narrative
Product analysis the device was returned loaded on a 0.014¿ guidewire the 150mm detached balloon was returned there was stretching on the outer shaft and bunching on the inner shaft medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Common Device Name: 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: 20408330
• Report Number: 2183870-2024-00340
• Device Sequence Number: 6517932
• Product Code: LIT
• UDI-Device Identifier: 00763000110185
• UDI-Public: 00763000110185
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K132777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AB14W040150150
• Device Catalogue Number: AB14W040150150
• Device Lot Number: B638625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male