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 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Physician was attempting to treat a lesion in the sfa/popliteal using in.Pact pacific paclitaxel eluting balloon catheter.It was reported that during balloon inflation, a balloon twist was noted preventing balloon inflation.Another balloon was used to complete the procedure.There was no injury to patient.¿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

Device evaluation: a visual and a tactile inspection was carried out on the device returned: dry blood and radiopaque solution was found on the device but no issue detected.The balloon was unfolded.There were slight wrinkles on the surface of the balloon when deflated but not signs of twist.The balloon was also observed under the microscope and no signs of twist was detected.The device was flushed and a 0.018¿ guide wire was successfully advanced from the tip to the hub of the device without issue.Then, the balloon was inflated sequentially at 2 bar and 7 bar without issues.The slight wrinkles were no more present on the balloon surface once inflated.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to treat a lesion in the sfa/popliteal using in.Pact pacific paclitaxel eluting balloon catheter.It was reported that during balloon inflation, a balloon twist was noted preventing balloon inflation.Another balloon was used to complete the procedure.There was no injury to patient.

• 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: 6390719
• MDR Text Key: 69441670
• Report Number: 9612164-2017-00253
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

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: 10/19/2019
• Device Catalogue Number: PCF06012009P
• Device Lot Number: 0008341424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• 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