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

Catalog Number CB1413540040OTW

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

Mw5107167.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a physician was attempting to use a chocolate otw balloon to treat a lesion in a patient.With heparin and via 7 french non-medtronic crossover sheath, the occlusion was crossed with the assistance of the angio safe chronic total occlusion crossing device, per protocol intervascular ultrasound was performed.It showed extreme soft plaque/thrombus.Initial plan was to use a chocolate balloon then a non-medtronic stent ¿ instead gentle angio with a 4.40 balloon was performed followed by a non-medtronic stent.This stent was post dilated by a chocolate balloon however after the second inflation the balloon became stuck despite numerous negative aspirations.On inspection of the balloon, the nitinol stent was not present and hard to see fluoroscopically, and ultrasound was used to find it.The device was snared multiple times, but it was difficult to get it into the sheath despite many maneuvers and then it would migrate.It was in a large segment of the prox right sfa.It was decided to crush the stent with a strong radial force interwoven stent.The stent was crushed by a 6 x 20 balloon for several inflations and a placement of a non-medtronic stent was performed.The stent was post dilated.Final ultrasound was performed from the right external iliac artery to the distal right peroneal artery with widely patent vessels.There was an 8 french angio-seal left femoral artery with good hemostasis and good pulses.No further patient injury reported for this event.

• 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: 14674691
• MDR Text Key: 294881235
• Report Number: 2183870-2022-00201
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CB1413540040OTW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2022
• 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