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.

Manufacturer Narrative

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.

• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

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: 03/02/2024
• Device Catalogue Number: CB1413540120OTW
• Device Lot Number: B5150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 02/25/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 58 KG