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

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

Patient Problem Embolus (1830)

Event Date 11/04/2016

Event Type  Injury  

Event Description

Physician was attempting to treat patient at the right mid popliteal artery.Lesion type was calcified with no tortuosity and moderate calcification.Physician advanced a 7 mm spider embolic protection device through a 7f sheath and a.035 trailblazer.A hawkone was then used to treat the lesion proximal to the filter.It is reported that directional artherectomy device did not come in contact with the filter.Lesion was then post-dilated using an impact admiral balloon.The spider device was retrieved with the trailblazer.The physician noted what appeared to be an embolus in the anterior tibial.Physician reported he doesn't know when exactly an embolus occurred due to many devices being taken in and out if sheath and across the lesion.The spider was reloaded into the delivery catheter to attempt to capture the embolus.It is reported that the spider would not re-insert into the sheath.It is reported that a second 7 mm spider was then used to complete the procedure.No further patient complications reported.

• 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: 6194179
• MDR Text Key: 62964611
• Report Number: 9612164-2016-01349
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/23/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/21/2016
• 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): Hospitalization