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

Catalog Number SBI050040080

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use an admiral xtreme balloon catheter along with a non-medtronic 0.035" guide wire during procedure.The vessel was severely tortuous.Resistance was encountered while advancing the device with excessive force used.Breakage of the balloon shaft part occurred.It was reported that during delivery, when the above admiral was used in the percutaneous shunt transluminal angioplasty (shunt pta), the shaft part fractured at a place where tortuosity of the anastomotic part was severe, and the fractured part remained in the body.The fractured part was successfully retrieved by using a snare.The guide wire was not delivered ahead, and it seemed that the shaft fractured when the force was applied due to severe tortuosity.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the admiral xtreme was returned inside a resealable zip-lock bag.The manifold indicated 80 cm working length and 5x40 balloon properties.No ancillary devices were included.The admiral xtreme was returned in two segments.The catheter shaft was fractured proximal to the balloon.The distal/balloon segment was returned inside a separate small resealable pouch.The segment was removed and inspected.The approximate length of the segment was 5.5cm.Under microscope the distal and proximal marker bands were identified.Dried blood was observed on the exterior and the interior of the balloon.The fracture face of the distal segment was located approximately 1cm proximal to the proximal marker band of the balloon.The fracture face was straight and ductile in nature.The proximal segment of the admiral xtreme was inspected.The approximate working length was 75cm.The fracture face of the distal segment was located approximately 1cm proximal to the proximal marker band of the balloon.The fracture face was straight and ductile in nature.The approximate grand total length of both segments was 80.5cm which aligns with 80cm working length indicated on the manifold assembly.Both fracture faces inspected show characteristics showed the catheter was likely encounter excessive forces during advancement and/or withdrawal.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: 10512812
• MDR Text Key: 206308603
• Report Number: 9612164-2020-03414
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K173515
• 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: 10/30/2020

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: 02/15/2023
• Device Catalogue Number: SBI050040080
• Device Lot Number: 219514232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention