MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CHOCOLATE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	CB1812060120OTW
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2025
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
It was reported that during a percutaneous transluminal angioplasty procedure to treat a peripheral/endovenous lesion with moderate calcification in the mid superficial femoral artery, the percutaneous transluminal angioplasty chocolate 018 balloon exhibited deflation difficulties.The device was slow to deflate at the lesion site, and deflation issues were noted during subsequent inflation.During the fourth inflation, the nitinol constraining wire failed to retract into the balloon.The procedure was completed by replacing the device with a 6-80 cb.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: no damage was noted to the balloon catheter and no issues occurred during inflation.A pressure pump was used to deflate the balloon and was fully deflated normally for removal, with routine pressure release.The device was somewhat difficult to remove, but was ultimately successfully retrieved.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
Product analysis the device was flushed, (photo 3) and an 0.018¿ guidewire was loaded, an indeflator was attached to the device and the balloon was inflated to nominal pressure of 6atms, the balloon was then inflated to rated burst pressure (rbp) of 12atms, the balloon was then fully deflated in approximately 10 seconds, 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): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo cucapah 10510 el lag; tijuana baja california,mx 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo cucapah 10510 el lag; tijuana baja california,mx 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23766954
• Report Number: 9617601-2025-03332
• Device Sequence Number: 10615316
• Product Code: LIT
• UDI-Device Identifier: 00763000500238
• UDI-Public: (01)00763000500238(17)280404(10)2300130(20)05
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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 Catalogue Number: CB1812060120OTW
• Device Lot Number: 2300130
• 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: 11/23/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 01/06/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/17/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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 Sex: Male