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

Catalog Number AMD025120152

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use the amphirion deep balloon during procedure to treat popliteal arteries.Moderate tortuosity and moderate calcification of blood vessels with 65% stenosis reported.It was reported that on using the balloon it failed to dilate and got stuck.No inflation difficulties.No leaks noted.Deflation issue was noted.No intervention required to remove device.No vessel damage.Little force was required to removed device safely from patient.No patient injury reported.

Manufacturer Narrative

Product analysis the device was returned with multiple kinks along the shaft a 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip a 0.014¿ guidewire from the lab was loaded into device with difficulty because of the kinks.The device was inflated to nominal pressure of 7 atms but the balloon could not inflate and then inflated to rated burst pressure of 14 atms but the balloon would still not inflate.This is most likely due to all the kinks on the device.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
• 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: 13504419
• MDR Text Key: 285396052
• Report Number: 9612164-2022-00549
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K052791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Catalogue Number: AMD025120152
• Device Lot Number: 219551455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 78 KG