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

Catalog Number PCF05012013P

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device was received for evaluation.A visual and a tactile inspection was performed and some kinks were found on the shaft at 32-33cm and 79cm from the strain relief.Another kink was observed on the balloon, at 4cm from the proximal marker.No further issues were detected.The device was flushed and a 0.018¿ guide wire was successfully advanced through the device.During the analysis, negative pressure was applied with a manometric syringe on the balloon.The purging test passed, since no bubbles emerged in the water column.The balloon was inflated at 2, 4, 7, 14 bars without issues detected nor on the balloon neither on the guidewire lumen.After the inflation test, the balloon was successfully deflated, without signs on the balloon surface and on the guidewire lumen image analysis: the images received show the constriction of the balloon during the inflation in the artery and it has been concluded that a balloon twist had occurred.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use an inpact pacific device with a reef pta balloon and 4 non-medtronic devices, to treat a mid-arteriovenous fistula.Artery diameter 5mm, lesion length 120mm.The reef pta was used before dcb was delivered with no issues reported.During the procedure the angiogram showed that the inpact pacific would not fully inflate at 8atm.The physician ended the case without any further intervention.No patient injury reported ¿please note that this device (inpact pacific) is not marketed in the united states; however, it is similar to the united states marketed device (inpact admiral).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

• 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: 7783998
• MDR Text Key: 117148827
• Report Number: 9612164-2018-02051
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 08/15/2018

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: 08/08/2020
• Device Catalogue Number: PCF05012013P
• Device Lot Number: 0008733073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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