MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT PACIFIC; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number PCF05012013P

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use an in.Pact pacific pta balloon catheter for the treatment of a lesion in the left sfa.Ifu was followed.A non-medtronic inflation device was used.It was reported that balloon inflation difficulties occurred during inflation.Inflation pressure unknown.Device did not pass through a previously deployed stent.No resistance was encountered.It was reported a leak from the hub occurred, making the inflation difficult.A new device was used to complete the procedure.No patient injury was reported.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

Device evaluation summary: the device has been returned for analysis.The information reported on the luer is consistent with the complaint form received (lot# 0008398648).A visual and tactile inspection has been performed: traces of blood were found.No other issue detected.The guidewire lumen has been flushed and a 0.018¿ guide wire has been successfully advanced through the device.Negative pressure was applied to the balloon: the device passed the purging test, since no bubble emerged in the water column.The balloon was inflated at 7 bar and then to 14 bar, resulting in the correct inflation of the balloon and no leakage was detected from the hub, in both attempts.No issue detected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT PACIFIC
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7116037
• MDR Text Key: 95071832
• Report Number: 9612164-2017-01928
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140010
• 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
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: PCF05012013P
• Device Lot Number: 0008398648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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 Age: 78 YR
• Patient Weight: 75