MAUDE Adverse Event Report: COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number CB1413540120OTW

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)

Event Date 11/05/2021

Event Type  Injury  

Event Description

Patient presented with a significant lesion to the common femoral artery, as well as the sfa/pop. Physician used a chocolate pta balloon with a 4/5fr slender sheath and 0. 014 non-medtronic 320cm guidewire during treatment of an 80mm calcified lesion in the patient's mid right anterior tibial artery. Slight vessel tortuosity and severe calcification are reported. Lesion exhibited 95% stenosis. Artery diameter reported as 4mm. The physician was unsuccessful in crossing from an antegrade approach and obtained pedal access to the anterior tibial artery, and inserted a 4/5 sheath. The physician was successfully able to cross the sfa pop lesion, and utilized a non-medtronic device to perform atherectomy. The physician requested a chocolate pta for post atherectomy balloon angioplasty. 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 device was prepped as per ifu without issue. A non-medtronic inflation device was used with 60/40 saline to contrast inflation fluid for balloon inflation. The device was not passed through a previously deployed stent, no resistance was noted during advancement. The chocolate balloon crossed the lesion with no issues and inflated properly. Upon removal of the chocolate pta, the physician encountered some resistance in the anterior tibial artery as the balloon was walked back. The physician believed that the chocolate balloon could possibility be caught in some calcified, and asked the technician to rapidly and slightly inflate the balloon and immediately deflate to create a negative suction. This was performed, and the chocolate balloon was successfully removed from the body. On removal of the device on the table the balloon was immediately inspected and it was noticed that the cage was no longer on the balloon. It was confirmed that the cage was embolized in the mid-anterior tibial artery. The physician then preformed 2 subsequent balloon inflations with a 1. 0, and 2. 0mm coronary balloons to restore a lumen to that portion of the artery. Patency was confirmed via angiography and the case was terminated. Upon removal of the pedal access sheath, doppler pulses were confirmed to the anterior tibial/dorsalis pedis. No injury reported.

Manufacturer Narrative

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

• Brand Name: CHOCOLATE
• 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: 12787259
• MDR Text Key: 280697796
• Report Number: 2183870-2021-00410
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130414
• 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
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CB1413540120OTW
• Device Lot Number: B5150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/10/2021 Patient Sequence Number: 1