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

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

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

Event Date 12/15/2021

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 chocolate pta balloon during procedure to treat severely calcified plaque in the distal mid left superficial femoral artery(sfa).The vessel had moderate tortuosity and exhibited cto (chronic total occlusiom-100%).The artery diameter was 6mm and lesion length was 180mm.A 6fr sheath was 0.018'' guidewire were used.Physiological inflation fluid was used.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.There was no alleged product issue.The device was passed through a previously deployed stent.No resistance was encountered when advancing the device.Patient nothing happened.It was reported that the physician misused the device inside a newly implanted stent.Confirming the device the stent meshes were incarcerated in the balloon cage so physician had to carry out repeated inflating and deflating maneuvers to detach the anchorage of the cap with the stent.After repeated operations he managed to swallow the device and take it out.Physician has acknowledged that they used chocolate under a no ifu condition resulting in a serious error of procedures and evaluation of the procedure.There was no damage caused to the stent.There was no intervention required to remove the balloon from the stent.There cage did not detach off the balloon.The device did not give any problems of any kind.No patient injury.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13151119
• MDR Text Key: 289665823
• Report Number: 2183870-2022-00004
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K130414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 110 KG