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

Catalog Number SBI050080080

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device was returned in the original packaging.The device was returned in the sealed original plastic pouch, not used in patient.The information reported on the compliance chart is not consistent with the product specifications (as indicated in the label applied on the box and pouch and as marked in the hub).The compliance chart wrongly refers to a balloon diameter of 6 mm, instead of 5 mm.A visual and a tactile analysis was carried out on the relevant device, no abnormalities were detected on the device itself.Finally, the balloon diameter was measured at the nominal pressure: the balloon diameter was 5 mm, confirming that the compliance chart does not correspond to the actual balloon size.(b)(4).

Event Description

The physician was using an admiral xtreme otw pta balloon catheter.It was noted during use that the compliance chart did not correspond to the balloon size.The device was successfully used in the patient with no clinical sequelae.Two additional devices with the same lot # were also found to have the incorrect compliance chart.The devices were removed from the facility by the sales rep.

• 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 IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5263171
• MDR Text Key: 32873026
• Report Number: 9612164-2015-01812
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: SBI050080080
• Device Lot Number: 208599953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2014
• 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