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

Catalog Number AMD025120152

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

Patient Problem Insufficient Information (4580)

Event Date 02/11/2022

Event Type  Injury  

Event Description

Physician was attempting to use the amphirion deep pta balloon during procedure to treat moderately calcified plaque in the mid anterior tibial artery.The vessel had moderate tortuosity and exhibited cto (chronic total occlusion-100%).There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.It was reported that there were balloon inflation difficulties.The event was observed during balloon inflation at nominal pressure.It was reported that the balloon would not deflate at the lesion site.The balloon entered the anterior tibial artery, and the expansion was very slow.After it slowly expanded, the pressure pump released the pressure, and the balloon couldn't be retrieved.After waiting for 30 minutes, it still couldn't be retrieved.Subsequently, the anterior tibial artery was percutaneously punctured with a puncture needle, and the balloon was punctured and retrieved normally after reaching the position of the balloon.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.No patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis 120mm balloon returned in its post inflated state.The device was flushed with a 20ml water filled syringe.A 0.014¿ guidewire was loaded through the tip; resistance was felt, and the guidewire could not be pushed through the guidewire port of the luer.The strain relief was removed, and a kink was visible on the guidewire lumen.The device was connected to a pressure gauge and inflated to nominal pressure 7atm and rated burst pressure 14atm.The device would not inflate.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.

Manufacturer Narrative

The supplemental reg report had the incorrect aware date correct aware date is (b)(6) 2022.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.

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.

• 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: 13522260
• MDR Text Key: 285531991
• Report Number: 9612164-2022-00603
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup,Followup
• Report Date: 06/28/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2024
• Device Catalogue Number: AMD025120152
• Device Lot Number: 221745332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 06/13/2022; 06/13/2022; 06/24/2022
• Supplement Dates FDA Received: 06/14/2022; 06/14/2022; 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male