MAUDE Adverse Event Report: MEDTRONIC MEXICO AMPHIRION DEEP OTW; CATHETER, PERCUTANEOUS

Catalog Number AMD020120152

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use an amphirion deep pta balloon during treatment of a calcified and plaque cto (chronic total occlusion-100%) in the patient¿s mid and distal left superficial femoral artery, posterior tibial artery, and anterior tibial artery.Slight vessel tortuosty and calcification are reported.There was no damage noted to the packaging.No issues noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.A syringe was used for balloon inflation with normal saline: contrast agent, 1:1 ratio.The device was not passed through a previously deployed stent.No resistance was noted during advancement.Balloon inflation difficulties are reported.At 7atm it is reported that the balloon was slow to deflate at the lesion site.No pinhole noted.No kink noted to balloon or catheter, nor any other damage to balloon catheter noted.No intervention required to deflate balloon.Device was safely removed from patient.A replacement balloon was used to complete the procedure.No patient injury reported.

Manufacturer Narrative

Device evaluation during visual inspection, kinks are evident on the catheter shaft at approx.38.2cm, 69.1cm, 108.5cm and 116.5cm distal from the strain relief.Inspection under the microscope shows both marker bands present on the balloon and are intact.A 20ml water filled syringe was used to flush the device with no difficulty.A 0.014¿ guidewire from the lab could not be loaded through the catheter due to the multiple kinks present on the catheter shaft.Negative prep performed with the syringe connected to the luer and no issues noted.An indeflator was connected to the balloon port of the luer and the balloon was inflated to nominal pressure (7atm) and rated burst pressure (14atm) with no issues noted.The balloon deflated within 12 seconds with no issues.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: AMPHIRION DEEP OTW
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 11795883
• MDR Text Key: 249724911
• Report Number: 9612164-2021-01814
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K052791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Catalogue Number: AMD020120152
• Device Lot Number: 220749200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR