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

Model Number AB14W060150150

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use the nanocross elite pta balloon during procedure to treat moderately calcified lesion in the proximal left superficial femoral artery(sfa). The vessel had little tortuosity and exhibited 80% stenosis. The artery diameter was 6mm and lesion length was 60mm. A 6fr sheath and non-medtronic guidewire were used. The balloon was inflated with a non-medtronic inflation device. There was no damage noted to packaging, i. E. , shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray. No damage was noted to the balloon catheter. No kinks were noted in balloon catheter or wire. It was reported that both inflation and deflation issues were noted. Balloon partially inflated then wouldn¿t deflate. There were balloon inflation difficulties at 8atm. It was reported that there were balloon deflation difficulties. Device would not deflate at the lesion site. Deflation issues noted following first inflation. Deflation issues noted during subsequent inflation. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. It took 15 minutes of backward pressure to get balloon deflated enough to go through the sheath. No patient injury.

• 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: 14117274
• MDR Text Key: 289327660
• Report Number: 2183870-2022-00142
• Device Sequence Number: 1
• Product Code: LIT
• 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

• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AB14W060150150
• Device Catalogue Number: AB14W060150150
• Device Lot Number: B338824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No