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

Catalog Number ADM07008013P

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: the protection sheath and stylet were found in place.A visual and tactile inspection were performed on the device: the tip was slightly damaged, while a kink was found on the shaft at 87cm of the working length and a little squeezed area at 31cm.Evident traces of blood were found on the device.The balloon was found folded, but used (bloodstained).The guide wire lumen was flushed and it was possible to insert the 0,035¿¿ guide wire without any resistance.The purging procedure was performed with no issues.In order to verify the correct profile of the balloon, the device was inserted in a 7f cordis introducer sheath.No resistance was felt both during insertion and extraction.

Event Description

Physician was attempting to treat a lesion in the sfa using in.Pact admiral paclitaxel eluting balloon catheter.The lesion exhibited medium level calcium with 90% stenosis at proximal sfa and lesion diameter is 7mm and length 60mm.The lesion was pre dilated prior to device use in patient.It was reported that the device failed to cross the lesion.Another 7mm diameter in.Pact admiral paclitaxel eluting balloon was used to complete the procedure with no issues noted.There was no injury to patient or clinical sequelae reported for this event.When the device was returned for evaluation, it was noted that the shaft of the device was damaged.

• 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: 5576786
• MDR Text Key: 42708034
• Report Number: 9612164-2016-00369
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2016

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: 03/10/2016
• Device Catalogue Number: ADM07008013P
• Device Lot Number: 0007498098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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