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

Catalog Number AMD025080152

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

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

Event Date 06/16/2021

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 amphirion deep pta balloon catheter during procedure to treat a little calcified plaque lesion in the mid posterior tibial artery (pta) and peroneal artery with 50% stenosis.The vessel was moderately tortuous.The vessel diameter and lesion length are 2.5mm and 75mm respectively.A non-medtronic indeflator was used for balloon inflation.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.Balloon inflation difficulties was observed at 7bar.The device would then not deflate at the lesion site.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.A pressure pump was used to deflate the balloon.The procedure was completed after withdrawing the faulty balloon, replaced with medtronic balloon of same size and model.There was no patient injury.

Manufacturer Narrative

Device evaluation under a microscope, slight bunching is noted at the proximal balloon bond.The balloon returned partially inflated.Both marker bands are visible and intact.A 10ml syringe was filled with water and connected to the guidewire port and attempted to flush but resistance was noted, and the device was unable to be flushed.A 0.014¿ guidewire from the lab was front loaded via the tip and a blockage was noted at approx.12.5cm proximal to the distal tip.The guidewire was loaded via the gw port of the luer and became stuck at the same location in the catheter.This was possibly due to contrast or biologic within the guidewire lumen.An indeflator was connected to the device and an attempt was made to inflate the balloon to nominal pressure (7atm) and rated burst pressure (15atm) however the balloon failed to 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.

• Brand Name: AMPHIRION DEEP OTW
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12073971
• MDR Text Key: 258611895
• Report Number: 9612164-2021-02494
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Catalogue Number: AMD025080152
• Device Lot Number: 221069022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70