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

Catalog Number ADM04015008P

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

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During the index procedure two in.Pact admiral dcb were used to treat the left prox, mid and distal sfa.Approximately 5 weeks post procedure the patient suffered critical limb ischemia reported as probably related to the target lesion and was treated with a pta.The event is resolved.The investigator and sponsor assessed the event as not related to the device, procedure or paclitaxel.

Manufacturer Narrative

Initial reporter and patient code corrected.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: 8934905
• MDR Text Key: 155648019
• Report Number: 9612164-2019-03595
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169576308
• UDI-Public: 00643169576308
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Catalogue Number: ADM04015008P
• Device Lot Number: 0008820015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/28/2019
• Date Device Manufactured: 10/03/2017
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 35