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

Catalog Number SBI080040130

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Physician intended to use an admiral xtreme device with a 6fr non-mdt sheath and non-mdt 0.035 guidewire for treatment of a severely calcified lesion in the mid right common iliac artery with little tortuosity.Embolic protection was not used.An non-mdt inflation device was used with contrast and saline.Ifu was followed and no issues were noted during prep.No excessive force used during insertion it is reported that a longitudinal burst occurred during first inflation at 12 atm.Physician went to 8atm then went up to 12atm when balloon burst.It is reported that both markers came off delivery system.Fragments were removed surgically -vessel opened in order to remove detached balloon and 2 platinum iridium markers that had dislodged off the balloon delivery system removed under guidance of image intensifier.Vessel was closed with sutures.Patient is reported as being alive with injury.

Manufacturer Narrative

Device evaluation summary: the balloon broke at approximately 1 cm from the proximal balloon welding.The distal part of the balloon was missing.The guidewire lumen underneath the balloon stretched.Signs of proximal marker crimping are still visible.The two markers were missing.The tip was missing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Angio images provided showed the procedure (guidewire loading, device loading, balloon inflation and device withdrawal).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; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c.,mx 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c.,mx 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6803576
• MDR Text Key: 83013581
• Report Number: 9612164-2017-01138
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: SBI080040130
• Device Lot Number: 211665337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR