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

Catalog Number PCF050200090

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Physician was attempting to treat a lesion using in.Pact pacific paclitaxel eluting balloon catheter.It was reported that during procedure physician noted a candy effect distally but not significant.There was no injury or clinicla sequelae reported for the patient.Please note that this device (in.Pact pacific) is not marketed in the united states; however, it is similar to the united states marketed device (in.Pact admiral).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

Manufacturer Narrative

Evaluation summary: the device involved in this reported event was updated to pacific xtreme.The device returned was analysed and evaluation result attached.A visual and tactile inspections were performed on the device and a kink was found on the shaft at the end of the strain relief.The guide wire lumen was flushed and it was possible to insert the 0,018¿¿ guide wire without any resistance.The balloon was observed and it was found slightly wrinkled at 16 cm from the proximal welding.The purging procedure was performed with no issues.The balloon was inflated at 1 bar and its profile resulted slightly deformed.This deformation disappeared increasing the inflating pressure.No issues found on the guide wire tube.No further issues found.

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 8500 ; MX 8500
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 4956205
• MDR Text Key: 24627725
• Report Number: 3004066202-2015-00356
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: PCF050200090
• Device Lot Number: 208359989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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