MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL 014; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number BTK03512015P

Device Problems Inflation Problem (1310); Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the procedure, it was reported that one in.Pact btk 3.5/120 mm balloon did not open completely during inflation.A "candy effect" was noticed which may nave caused no elution in the non-expanded zone which was less than 1 mm of the balloon.This caused eventual geographic miss.For this reason, that specific zone, has been eluted with an additional balloon.Please note that this device in.Pact admiral btk pta balloon catheter is not marketed in the united states; however, it is similar to the united states marketed device in.Pact admiral pta balloon catheter.This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

Manufacturer Narrative

Product analysis: the device was returned for analysis.The balloon was found unfolded and showed a twist 5 cm from the tip.After the decontamination, the technical analysis was performed.It was not possible to insert the 0,014'' guidewire as there was dried blood in the guidewire lumen.Negative pressure was applied to the inflation lumen: no bubbles emerged in the water column.The balloon was inflated and observed under microscope: at 2 bar the balloon showed slight signs of twist and a slight constriction of the balloon profile in correspondence of the twist was visible at 4 bar: slight signs of a twist was visible and constriction in the profile was observed at 7 bar: there were no signs of a twist on the balloon surface.At 14 bar: there were no signs of a twist on the balloon surface.After balloon deflation, slight wrinkles on the surface of the balloon were visible which were in correspondence with the twist.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: IN.PACT ADMIRAL 014
• 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: 7721603
• MDR Text Key: 115355627
• Report Number: 9612164-2018-01848
• Device Sequence Number: 0
• Product Code: ONU
• Reporter Country Code: IT
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2018
• Device Catalogue Number: BTK03512015P
• Device Lot Number: V07482258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 08/08/2018
• Supplement Dates FDA Received: 08/29/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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: 79 YR