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

Catalog Number	CB1415025120OTW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: it was reported that the "balloon had a break", this refers to a leak, the balloon failed to inflate and the fluid that filled the balloon flowed out of the balloon's surface.Not further deformation or detachment noted to the balloon.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional 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.
Event or Problem Description
A physician was using a chocolate pta balloon for treatment of a fibrous lesion with chronic total occlusion in the proximal region in the posterior tibial artery and anterior tibial artery.There was mild tortuosity and calcification.The device was prepped as per the ifu with no issues identified.The device did not pass through a previously deployed stent and no resistance was encountered during delivery to the lesion.It was reported the balloon entered the patients body and reached the lesion.During inflation the balloon could not be fully inflated.The balloon was removed from the patient, and it was found it could not be inflated.Liquid was flowing out of the balloon and the physician noted the balloon has a break.Another balloon of the same model was used to complete the case.No patient injury.
Additional Manufacturer Narrative
Product analysis the device was flushed, and a 0.014¿ guidewire was loaded, an attempt was made to inflate the device, but this was unsuccessful possibly due to hardened biologics or saline in the inflation lumen.The device was left in warm water overnight in an attempt to dissolve the blockage, but this was unsuccessful.Due to the condition of the returned device no functional testing could be carried out.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CHOCOLATE
• Common Device Name: 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: 18911987
• Report Number: 2183870-2024-00087
• Device Sequence Number: 6892920
• Product Code: LIT
• UDI-Device Identifier: 00763000430498
• UDI-Public: 00763000430498
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P210039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2024

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: 07/05/2025
• Device Catalogue Number: CB1415025120OTW
• Device Lot Number: 1073454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 05/02/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/11/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female