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

Catalog Number ADM06008013P

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: visual and tactile inspection were performed on the device: a wide stretched area was found on the shaft after the end of the strain relief and the proximal balloon welding was found stretched as well.No further issues were found.Evident traces of blood were found on the device.The balloon was found folded.The guide wire lumen was flushed, but, due to the damaged portion of the shaft, it was not possible to insert the 0 ,035¿¿ guide wire.The purging procedure was performed with no issues.In order to verify the correct profile of the balloon, the device was inserted in a 6f introducer sheath.No resistance was felt both during insertion and extraction.No other issues were found.(b)(4).

Event Description

Physician was attempting to treat a lesion in the sfa using in.Pact admiral paclitaxel eluting balloon catheter.The lesion is severely calcified and vessel exhibited little tortuosity.The device was removed from packaging as per ifu, inspected and prepped with no issues noted.It was reported that the lesion was pre dilated with a 6mm admiral xtreme balloon catheter successfully.The device was advanced to the target lesion but it failed to cross the lesion.Severe resistance was encountered when advancing the device.The physician felt as if it was a wire tracking issue with the dcb.A regular admiral was successfully used for pre-dilatation.After pre-dilation the in.Pact admiral was advanced but was unable to cross lesion.Physician noted that a lot of pull back withdrawal force was used to remove in.Pact admiral.Physician believes that it was a wire issue.The in.Pact admiral dcb was delivered over a 0.035 glide advantage wire.After the in.Pact admiral did not cross the physician went in with a 0.035 admiral, crossed the lesion, and angioplastied the lesion.Got great results and then the case was done.When the device was returned to the manufacturing facility, it was noted that the shaft was stretched.

• 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: 5264040
• MDR Text Key: 32830242
• Report Number: 9612164-2015-01815
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2016
• Device Catalogue Number: ADM06008013P
• Device Lot Number: 0007423268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• 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