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

Catalog Number CB1413535120OTW

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a chocolate balloon during treatment of an in-stent restenosed fibrous cto (chronic total occlusion-100%) in the patient¿s mid right tibial/popliteal trunk.Slight tortuosity reported.A non-medtronic inflation device was used for balloon inflation.Ifu was followed and the balloon was prepped without issue.It is reported that during attempted removal of the balloon from the lesion, a break occurred on the catheter leading to a detachment.It is suspected that the balloon became caught on stent strut.A snare was used to retrieve the detached portion from the patient.

Manufacturer Narrative

Additional information: a 6fr non-medtronic sheath and 0.014 guidewire were also used.The chocolate balloon was passed through a previously deployed non-medtronic stent.No damage was caused to the previously deployed stent.Minimal resistance was encountered during removal of the device.The balloon was fully deflated for removal from the patient.The patient is reported to be doing well with a good result achieved.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CHOCOLATE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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 ; 091708734
• MDR Report Key: 8934776
• MDR Text Key: 156082687
• Report Number: 2183870-2019-00420
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CB1413535120OTW
• Device Lot Number: F180118500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Date Device Manufactured: 01/18/2018
• 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 Outcome(s): Required Intervention