MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	PCU060250130
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a pacific xtreme pta balloon with a 6fr non-medtronic sheath and non-medtronic guidewire during treatment of a 200mm calcified lesion in the patient¿s mid left superficial femoral artery (sfa) of diameter 6mm.Slight vessel tortuosity and severe calcification is reported.No damage noted to product packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The device was not passed through a previously deployed stent.No resistance is reported during advancement of the device.50/50 saline/contrast mix was used for balloon inflation.It is reported that a balloon burst occurred during inflation of the balloon.It is reported no balloon fragments were left in the patient.The physician then decided to treat with an everflex entrust self-expanding stent system using the same sheath and wire.No damage noted to product packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.No resistance was encountered during advancement.It is reported the everflex entrust stent was unable to cross the lesion.The physician then used a non-medtronic stent to complete the procedure.No patient injury reported.
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.
Additional Manufacturer Narrative
Additional information: the balloon did not fragment.No vessel damage was noted and the balloon was safely removed from the patient without intervention.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.

• Brand Name: PACIFIC XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9920202
• Report Number: 9612164-2020-01465
• Device Sequence Number: 3296729
• Product Code: LIT
• UDI-Device Identifier: 08033477075877
• UDI-Public: 08033477075877
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2020

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: 09/25/2022
• Device Model Number: PCU060250130
• Device Catalogue Number: PCU060250130
• Device Lot Number: 218569123
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 04/03/2020; 05/14/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/07/2020; 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1