MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS US; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	PCP070040150
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician attempted to use a 2.5x60mm pacific plus pta balloon during treatment of the patient¿s common iliac vein (civ) & external iliac vein (eiv).The device was passed through a previously deployed stent.An inflation device was used.50/50 contrast inflationfluid was used.Tracking difficulty during initial advancement was reported.Moderate resistance was noted, other balloon (bard atlas) was unable to cross the lesion.It was reported that the 2.5x60mm pacific plus balloon got stuck on an 018 non-medtronic wire and was safely removed with the wire from the patient.The physician then attempted to use a 7x40mm pacific plus pta balloon.It was reported that the 7x40mm pacific plus got stuck and detached at the target lesion as they tried to remove it.Only a partial piece of the balloon was removed.The detached component was left in the patient.Physician then attempted to use a nanocross elite pta balloon to pull out the detached 7x40mm pacific plus but the nanocross elite also got stuck and detached, the nanocross was removed with a snare.The detached nanocross elite was removed from the patient.Procedure was aborted.The patient may need surgical intervention to remove the remaining piece.
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.
Additional Manufacturer Narrative
Additional information: it was reported that the remaining piece was retrieved with an endovascular approach.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 returned loaded on a 0.014¿ guidewire, approximately 22mm of the balloon was returned.The inner is stretched on the 0.014¿ guidewire and no markerbands are present, 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: PACIFIC PLUS US
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20706732
• Report Number: 9612164-2024-05356
• Device Sequence Number: 20878112
• Product Code: LIT
• UDI-Device Identifier: 08033477072906
• UDI-Public: 08033477072906
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K123358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: PCP070040150
• Device Lot Number: 226888846
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 04/15/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/12/2025; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female