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

Catalog Number PCF05012009P

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the visual appearance of the balloon showed slight signs of a twist 3 cm from the proximal balloon welding.After the decontamination visual and tactile inspection were performed: it was found unfolded, full of dried contrast medium, with a point of constriction and wrinkles on the surface at 3 cm from the proximal balloon welding.The 0,018¿¿ guide wire was loaded without any issue.During the analysis, negative pressure was applied with a manometric syringe on the balloon: no bubbles emerged in the water column.The balloon was inflated and observed under microscope.Balloon was visually observed: 2 bar: it was showing wrinkles in correspondence of the constriction - 7 bar and 14 bar: wrinkles were no more detected.The balloon was fully inflated.A slight constriction was present on the guide wire lumen in correspondence of the twist, however this damage do not prevent the guidewire passage.Evaluation, 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.Evaluation ,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.

Event Description

Physician was attempting to treat a diffused lesion and little calcified in the sfa using in.Pact pacific paclitaxel eluting balloon catheter.The lesion exhibited 75% stenosis.It was reported that it was not possible to inflate the dcb properly.Pre dilatation was performed as required using a 5mm pacific plus balloon catheter.At certain part balloon was kind of compressed and for that reason not inflated over the whole length of the balloon.Consequently, the drug was not delivered on the whole area of the lesion.Second inflation was performed with same insufficient inflation of the balloon.Balloon was inflated again outside of patient and the point of obstruction was seen at that time.First inflation was to 6 atm for 90 secs and second inflation to 8 atm for 60 secs.¿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

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: 6338603
• MDR Text Key: 67654849
• Report Number: 9612164-2017-00185
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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: 01/19/2017

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: 01/04/2019
• Device Catalogue Number: PCF05012009P
• Device Lot Number: 0007879288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: 01/19/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2016
• 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: 70 YR
• Patient Weight: 80