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

Catalog Number	CB1413540120OTW
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an attempt was made to use a chocolate balloon to treat a calcified plaque lesion in the mid popliteal artery.Degree of tortuosity was little.Degree of calcification was moderate.Lesion stenosis was 80%.Embolic protection was not used.The balloon was inflated with a balloon.Device was prepped per ifu.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.There was difficulty removing balloon following balloon inflation, repeated pulling was required because the guide wire caught on the balloon.There was no vessel damage and the device was safely removed from the patient.Procedure completed by replacing the balloon.No patient injury reported.When the device was returned for evaluation, it was noted that the balloon was detached.
Additional Manufacturer Narrative
Product analysis: the device was returned with the balloon detached.The detached balloon was stuck on a 0.014¿ guidewire, a visual inspection confirmed that the balloon detached at the balloon bond.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: 19622797
• Report Number: 2183870-2024-00199
• Device Sequence Number: 8204825
• Product Code: LIT
• UDI-Device Identifier: 00763000430467
• UDI-Public: 00763000430467
• 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
• Report Date (Section B): 06/27/2024

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: 09/26/2025
• Device Catalogue Number: CB1413540120OTW
• Device Lot Number: 1082968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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: 71 YR
• Patient Sex: Male