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

Catalog Number ADM05012013P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

Image review: two images have been provided showing the patient's leg with rash.The two photos are of the patient¿s lower leg.The patent¿s skin has tiny red dots in both pictures.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

Patient had bilateral iliac stents.Three in.Pact admiral balloon catheters were used to treat the lesion in the popliteal to popliteal/tibial trunk.Protege stent was implanted in the iliac artery to complete the procedure.Physician flipped patient over and accessed the popliteal artery to deliver the dcb into the sfa.Patient had just recently had shingles.Dr.(b)(6) was the physician that did the procedure but sales rep was contacted by dr.(b)(6) the following week.Patient had shingles prior to this but physician said the rash was different than the shingles.The sfa mid to distal was treated through popliteal access however no rash occurred on this portion of leg it was all distal to area treated.Patient was treated with steroids.Steroid was delivered orally steroid dose pack.

Manufacturer Narrative

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: 6489251
• MDR Text Key: 72652783
• Report Number: 9612164-2017-00437
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169383630
• UDI-Public: 00643169383630
• 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,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2017
• Device Catalogue Number: ADM05012013P
• Device Lot Number: 0007853066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Date Device Manufactured: 12/07/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 57 YR