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

Model Number	AB14W050150150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
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
It was reported that an attempted was made to use two (2) nanocross elite balloons in a patient to treat the peripheral artery(s), s uperficial femoral artery.A non-medtronic inflation device was used (merit).50/50 contrast was used.It was reported that deflation difficulties occurred that took 10 minutes to deflate.Negative pressure with a syringe was used to deflate the balloon and the balloon eventually deflated.Deflation difficulties occurred with 2 devices.Another nanocross elite balloon was used to complete the procedure successfully.No health consequences or impact to a patient was reported for this event.
Additional Manufacturer Narrative
Product analysis: the device was returned with the balloon in a post-inflated state.An indeflator was used to attempt to inflate the balloon but the balloon could not be inflated.Under a microscope, crimping marks were noted on the proximal balloon bond.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 ELITE 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: 21090929
• Report Number: 2183870-2025-00008
• Device Sequence Number: 20989890
• Product Code: LIT
• UDI-Device Identifier: 00763000758165
• UDI-Public: 00763000758165
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AB14W050150150
• Device Catalogue Number: AB14W050150150
• Device Lot Number: B736200
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/24/2025
• Date Device Manufactured: 05/22/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0904-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose