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.

• 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
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• 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
• Reporter Country Code: JA
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SBI050040080
• Device Lot Number: 219514232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/10/2020 Patient Sequence Number: 1