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

Model Number	CB1413540120OTW
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a chocolate pta balloon during procedure to treat a moderately calcified lesion in the mid superficial femoral artery (sfa) to popliteal artery with chronic total occlusion (cto-100%).The vessel was moderately tortuous.A pressure pump was used for inflation device.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that during delivery through the vessel, balloon break/fracture occurred.The broken wire was not completely separated from the balloon.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.The device was safely removed from patient.No intervention required for removal.No vessel damage noted.Another chocolate balloon of the same model was used instead for dilatation, and the procedure was successfully completed.There was no patient injury.
Additional Manufacturer Narrative
Device evaluation the device returned in its post inflated state with biologics on the balloon profile.Visual inspection under a microscope shows a break/fracture to the chocolate cage at the proximal end of the balloon just proximal to the proximal marker band.Bunching is noted along the proximal balloon bond.The distal marker band is visible and intact.No deformation noted to the distal tip or the remainder of the chocolate cage.Image review one photograph was provided by the customer.The photograph shows the chocolate pta device in vitro.The photograph clearly shows the break on the proximal end of the chocolate cage with a cage wire sticking out.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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12281228
• Report Number: 2183870-2021-00281
• Device Sequence Number: 3681648
• Product Code: LIT
• UDI-Device Identifier: 00763000336677
• UDI-Public: 00763000336677
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: CB1413540120OTW
• Device Catalogue Number: CB1413540120OTW
• Device Lot Number: B5149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR