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

Catalog Number PCU060200130

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A physician was attempting to use a pacific xtreme to treat a moderately calcified, moderately tortuous fibrous lesion in the sfa with 90% stenosis.It was reported that during balloon inflation, balloon the center of the balloon would not inflate, a balloon twist occurred, the balloon would not unwrap.The twist occurred during inflation at 12 atm.The device passed through a previously deployed stent.The procedure was completed using another balloon.There was no injury to patient.

Manufacturer Narrative

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

• Brand Name: PACIFIC XTREME
• 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: 6639448
• MDR Text Key: 77510904
• Report Number: 9612164-2017-00754
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08033477035307
• UDI-Public: 08033477035307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: PCU060200130
• Device Lot Number: 211401920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Date Device Manufactured: 06/09/2016
• 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