MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number SBI07008013P

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During an attempt to treat a moderately calcified lesion in the sfa using in.Pact admiral paclitaxel eluting balloon catheter, it was reported that balloon could not be inflated because it was twisted.There were no issue noted during removal from packaging, during preparation and the device was prepped as per ifu.Physician completed procedure with another drug coated balloon.There was no injury to patient or other sequelae reported for this event.

Manufacturer Narrative

A visual and tactile inspections were performed on the device.The balloon was found bloodstained but partially folded, without evidence of inflation.The proximal part of the balloon was found damaged.A bunched area involves the proximal neck of the balloon and the distal part of the shaft.The guide wire lumen was flushed and it was possible to insert the 0,035¿¿ guide wire without any resistance, despite the mentioned bunched area.The purging procedure was performed with no issues.In order to verify the correct profile of the balloon and exclude a friction with the is, the device was inserted in a 7f cordis introducer sheath.No resistance was felt both during insertion and extraction.The balloon was inflated and observed under a microscope.No typical signs of twist were found, but, observing the guide wire tube underneath the balloon, it was possible to observe that the bunch involved also the guide wire tube.No further issues found.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.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• 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: 6123872
• MDR Text Key: 60751008
• Report Number: 9612164-2016-01184
• 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: 12/07/2016

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: 01/26/2019
• Device Catalogue Number: SBI07008013P
• Device Lot Number: 0007912937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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