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

Catalog Number	CB1812060080OTW
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
A chocolate pta balloon was being used for treatment of a calcified lesion with 60% stenosis in the distal region of the common iliac artery.A non medtronic inflation device was used.The chocolate balloon was prepped as per the ifu with no issues identified.There was no resistance while advacing the device and the device did not pass through a previously deployed stent. after the standardized surgical operation, the 18-wire guide passed through the lesion.The lesion was not short segment narrowed, and a chocolate balloon was selected for direct dilatation.Used a pressure pump to slowly inflate the chocolate balloon.After three minutes of dilatation, the balloon was deflated.When it was withdrawn from the body, it came into contact with the 6f sheath and could not be withdrawn smoothly.It was slightly inflated and deflated again in the body.After repeated it twice, it was withdrawn from the body with difficulty.
Additional Manufacturer Narrative
Product analysis: the device could be fully advanced and retracted through a 6fr sheath from the lab without any issue.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: 19928962
• Report Number: 2183870-2024-00241
• Device Sequence Number: 14164670
• Product Code: LIT
• UDI-Device Identifier: 00763000430573
• UDI-Public: 00763000430573
• 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
• Report Date (Section B): 10/12/2024

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: 07/04/2025
• Device Catalogue Number: CB1812060080OTW
• Device Lot Number: 1073383
• 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: 07/28/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/12/2024
• Date Device Manufactured: 07/04/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 56 KG