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

Model Number AB14W025120150

Device Problems Burst Container or Vessel (1074); Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 12/06/2021

Event Type  Injury  

Event Description

Physician was attempting to use the nanocross balloon catheter during procedure to treat severely calcified lesion in the mid and proximal right tibial/popliteal trunk (tpt) and peroneal artery. The vessel had no tortuosity and exhibited 80% stenosis. The artery diameter was 2. 5mm and lesion length was 40-50mm. A non-medtronic 7fr sheath and non-medtronic 0. 014'' guidewire were used. The balloon was inflated with a non-medtronic inflation device. Inflation fluid of 50-50 contrast and saline was used. There was no damage noted to packaging and no issues when removing the device from the hoop/tray. The device was prepped per the ifu with no issues. The balloon did not pass through a previously-deployed stent. There was no stent present in the vessel bed in the patient's right leg. It was reported that guidewire lock-up occurred during procedure in tandem with a longitudinal balloon burst at 8atm. The balloon was used to dilate a cto anterior tibial artery multiple times successfully and when redirected to tibial peroneal trunk artery the balloon ruptured on first inflation. All fragments were not retrieved. The physician made multiple attempts to retrieve remaining parts of balloon(distal catheter tip, distal balloon marker and some residual balloon material that separated from the balloon catheter) us ing a 4mm gooseneck snare but was unsuccessful. The detached portions remain in the patient as were difficult to remove. Resistance was encountered advancing the device and excessive force was used during delivery and withdrawal. Prior to intervention, anterior tibial artery was cto, proximal and mid tpt was heavily calcified and diseased, posterior tibial artery was cto, peroneal artery was distally occluded. After multiple unsuccessful tries with gooseneck snare, post angiogram showed anterior tibial artery was patent (it was angioplastied with same 2. 5 x 120 x 150 nanocross earlier). The unsuccessful use of the snare was due to diffuse disease and heavy calcium present at the location, where the foreign object was dislodged, unable to pass snare catheter through occluded artery in order to retrieve the foreign object. The snare was removed successfully from the patient's body without any incident and all intact. Tpt was now sub occluded with balloon marker and distal tip remaining inside. No additional procedure was performed after the incident. No other upcoming procedures are scheduled for the patient, but the patient is scheduled for a follow up appointment. Patient removed to recovery room and is reported to be doing well.

Manufacturer Narrative

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

• 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: 13008948
• MDR Text Key: 282264907
• Report Number: 2183870-2021-00457
• Device Sequence Number: 1
• Product Code: LIT
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AB14W025120150
• Device Catalogue Number: AB14W025120150
• Device Lot Number: B295439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/15/2021 Patient Sequence Number: 1