MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME OTW; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number SBI120020130

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A physician was attempting to use admiral xtreme pta balloon dilatation device to treat a lesion during procedure.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with issues identified.It was reported the paramedics noted a difference between the real balloon size (40mm measured by nurse) and the size notified on the box (20mm).Physician used another balloon to complete the procedure.Another balloon was used to complete the procedure.It is unclear if the device was used in the patient, however, no patient injury reported for this event.

Manufacturer Narrative

Additional information: the device was used in the patient.The device was safely removed from the patient.Device evaluation the admiral xtreme catheter device returned loosely coiled in its pouch inside a sterile pouch inside an outer package.Shelf carton also returned.Barcode on luer scanned:220399807.Lot number on pouch and shelf carton confirmed as 220399807, (photos 1 to 4).No ancillary devices or cine images from the procedure were received for evaluation.Device was decontaminated with cidex opa solution soak and tergazyme soak.The shelf carton label and the pouch label confirm that this is a 12 x 20mm balloon.A 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip.A 0.035¿ guidewire was loaded through the tip and exited the hub without any difficulty.A negative prep was performed with no issues.An indeflator with pressure gauge was used to inflate the balloon to nominal pressure of 6 atms with no issues.The markerband spacing was measured and measured 20mm.The balloon was then inflated to rated burst pressure of 6 atms with no issues.The balloon deflated with no issues.The markerband spacing was confirmed to be 20mm during functional testing in the lab.The length of the balloon is determined by the distance between the marker bands as opposed to the distance between the balloon cones.As the marker spacing was confirmed to be 20mm and this corresponds to the pouch and shelf carton labels there is no mislabeling issue.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: ADMIRAL XTREME OTW
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 11677151
• MDR Text Key: 245760707
• Report Number: 9612164-2021-01494
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K062809
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2023
• Device Catalogue Number: SBI120020130
• Device Lot Number: 220399807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1