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

Catalog Number SBI05012008P

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use an inpact admiral to treat a long 120mm lesion in the patient¿s superficial femoral artery (sfa).Artery diameter was 5mm.The device crossed the lesion and was inflated for approx.1 minute.It was reported that the balloon could not be deflated fully and then burst into two parts as it was pulled back through the sheath.The detached part of the device was retrieved from the patient using a non medtronic snare.The procedure was completed with another inpact admiral with no issues and the patient is feeling fine.No patient injury was reported.

Manufacturer Narrative

Additional information: the lesion was moderately calcified.The device was inflated using a syringe with no issues noted.Evaluation summary: the device returned, with guide catheter and a non-medtronic snare device.A detachment was evident on the catheter shaft approx.67cm distal to the strain relief, and proximal to the balloon bond.The catheter shaft material was stretched, jagged and uneven on both sides of the detachment site.The distal detached portion of the device and balloon were loaded in the guide catheter.The guide catheter tip was folded inwards.The distal detached portion of the device was removed from the guide catheter, along with the snare.Congealed blood and residue was visible on the balloon material.The balloon appeared to be fully deflated.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: 8568769
• MDR Text Key: 143682451
• Report Number: 9612164-2019-01539
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Catalogue Number: SBI05012008P
• Device Lot Number: 0009563390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• 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