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

Catalog Number AMD025080152

Device Problem Deflation Problem (1149)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

An amphirion deep balloon was being used during a procedure.It is reported that balloon deflation difficulties were encountered and the device would not deflate at the lesion site.The deflation issues were noted following first inflation and during subsequent inflation.The balloon was removed carefully.No patient injury reported.

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.

Manufacturer Narrative

Additional information: there were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu.There were no patient symptoms or complications associated with this event.Site location associated with this event was the tibial posterior, distal artery (2.5mm diameter).Stenosis target lesion with no degree of tortuosity and a moderate degree of calcification.The balloon was inflated using a inflator device.The device passed through a previously-deployed stent.No resistance was encountered when advancing the device.The balloon was retrieved with a lot of force.There was no patient symptoms or complications associated with this event.Intravenous prehydration with 1000 ml nacl /12h on the evening before the intervention.Pre-interventional, in-depth study of the results of clinical and technical examinations.Timeout with the entire team.Disinfection and local anesthesia of the right groin.Anterograde single puncture of the anterior wall of the common femoral artery.Insertion of a sheath with an outside diameter of 7.44 f (terumo radiofocus) over a terumo 35 wire.Survey angiography: this shows a high-grade, heavily calcified afs.In addition, the ata is closed from its origin and the adp has 2 stenoses distally.Application of 5000 iu heparin.Bare metal stenting pta of the afs on the right and pta of the atp with 2.5/80 and 2/40mm balloon.The 2.5/80 balloon does not deflate easily, despite using a second pressure gauge and an aspiration syringe.It can still be removed.Finally, pedal pta with a 2/40mm balloon of the posterior tibial artery.Finally good result.Removal of the catheter material and closure of the groin using starclose, which primarily holds.There is still some bleeding from the skin incision.Therefore, manual compression until hemostasis and additional application of a pressure bandage for four hours.Detailed image documentation is carried out in the pacs hirslanden clinic aarau.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: 17930601
• MDR Text Key: 325608359
• Report Number: 9612164-2023-04659
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2023

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 Catalogue Number: AMD025080152
• Device Lot Number: 226547032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/23/2023
• Date Device Manufactured: 05/10/2023
• 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