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

Catalog Number PCF06012009P

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the visual appearance of the balloon showed slight signs of a twist 4.5 cm from the tip.After the decontamination visual and tactile inspection were performed: it was found unfolded, full of dried contrast medium, with a twist 4.5 cm from the tip.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.At 2 bar it was still showing slight signs of twist.At 7 bar and 14 bar twist was no longer detected.No twist was present on the guide wire lumen.After the balloon deflation it was still possible to see slight wrinkles on the surface in correspondence of the twist.Continued from block evaluation codes: 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 codes: 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.

Event Description

Physician attempted to treat patient at the superficial femoral artery using an in.Pact pacific balloon.No issue was noted prior to use.No issues noted when advancing the device to the target lesion.It is reported that a balloon twist occurred.A second in.Pact pacific balloon was used to complete the procedure.No patient injury 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

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: 6331322
• MDR Text Key: 67440287
• Report Number: 9612164-2017-00176
• 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,consum
• Reporter Occupation: Other
• 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: 08/26/2019
• Device Catalogue Number: PCF06012009P
• Device Lot Number: 0008196398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: 01/19/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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