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

Model Number AB14W030100150

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

Image analysis: the customer returned a video clip and an image.The image shows the patient¿s vasculature with contrast in the artery.Based on the image and video clip the complaint of a balloon rupture cannot be confirmed.Device analysis: the device was flushed and a 0.014¿ guidewire was loaded.An indeflator with pressure gauge was used to inflate the balloon, but no pressure could be maintained, and the balloon exhibited a pinhole leak.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.

Event Description

A physician attempted to use two nanocross balloons during treatment of calcified lesions with chronic total occlusion in the superficial femoral artery (sfa) and the tibial/popliteal trunk (tpt).The diameter of the sfa was 5mm and the tpt was 3mm.The length of the lesion was 20-40mm.The degree of tortuosity and calcification was moderate.A 6fr non medtronic sheath and a nitrix guidewire were used.The devices were prepped as per the ifu with no issues identified. the balloons were inflated using a non medtronic device with hep saline 60/contrast 40.It was reported the physician initially used a 3mm balloon to pre dilate the chronic total occlusion in the sfa.Hawkplus m was used successfully.Physician attempted to inflate a 5mm nanocross balloon and it ruptured at 8 atm during the initial inflation and was removed intact with no fragments noted.Then attempted to inflate a 3mm balloon in the tpt unsuccessfully, it did not register pressure and had one inflation at 8 atm for two minutes, burst and was removed intact with no fragments noted.They then used 2.5-100 nanocross successfully in tpt and deployed an entrust stent.The sfa was post dilated with a nanocross at 8 atm for 2 mins.No vessel injury observed and no patient injury was reported.

• Brand Name: NANOCROSS 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: 16626251
• MDR Text Key: 312413954
• Report Number: 2183870-2023-00090
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000109820
• UDI-Public: 00763000109820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2023
• Device Model Number: AB14W030100150
• Device Catalogue Number: AB14W030100150
• Device Lot Number: B026496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Date Manufacturer Received: 03/15/2023
• Date Device Manufactured: 05/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 67 KG