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

Catalog Number PCF06012013P

Device Problems Burst Container or Vessel (1074); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2016

Event Type  malfunction  

Event Description

Physician was attempting to treat a lesion using in.Pact pacific paclitaxel eluting balloon catheter.It was reported that balloon twist during inflation and the balloon burst.Physician completed the procedure by using another in.Pact pacific.There was no injury to patient or clinical sequelae reported for this event."pease 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

(b)(4).Results: operational problem - the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion.Conclusion: operational context caused or contributed to event - the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion.Device evaluation: a visual and a tactile inspection was carried out on the returned device: dry blood was found on the device and inside the guide wire tube and a twist was found on the balloon at 42 mm from the tip.The visual inspection did not report any other issue on the device.The device was flushed and a 0.018¿ guidewire was successfully advanced through the device from the tip to the luer.During the analysis, negative pressure was applied with a manometric syringe on the balloon: the purging test did not pass, since bubbles emerged in the water column.Afterwards, an attempt to inflate the balloon was performed, in order to detect the leakage.Signs of a longitudinal burst was detected.

• 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: 5966644
• MDR Text Key: 55274007
• Report Number: 9612164-2016-00990
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/29/2016

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: 10/02/2018
• Device Catalogue Number: PCF06012013P
• Device Lot Number: 0007771180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2015
• 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