MAUDE Adverse Event Report: COVIDIEN CHOCOLATE; CATHETER, PERCUTANEOUS

Catalog Number CB1413540040OTW

Device Problems Break (1069); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 03/06/2018

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 with a non-medtronic 6fr sheath and 014 non-medtronic guidewire for the treatment of a de novo lesion in the patient¿s popliteal artery.It is reported there was no degree of calcification nor was the vessel tortuous.Embolic protection was not used.The device was prepped as per the ifu without issue.The device did pass through a previously deployed stent.It is reported that resistance was encountered when advancing the device but that no excessive force was used.The balloon was inflated in the lesion successfully but during removal the body was caught on a previously placed stent which had been placed in a procedure approximately 3-5 months prior.The segment of broken cage was successfully tacked down using another stent and there was no flow limitation noted.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: after decontamination of the device it was examined under the microscope.The analysis demonstrates that the device was removed against significant resistance.Greater than 10n.Leading to the detachment of the cs from the unit.Based on the lot records review, there is no indication that the devices had low cs bond strength.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CHOCOLATE
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 7725815
• MDR Text Key: 115207188
• Report Number: 2183870-2018-00399
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CB1413540040OTW
• Device Lot Number: F170630500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 01/28/2019
• Supplement Dates FDA Received: 10/02/2018; 01/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• 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
• Patient Age: 82 YR