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 Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used an in.Pact admiral with a 6fr sheath and non-mdt 0.035" guidewire for treatment of an 80mm moderately calcified soft tissue lesion in the patients proximal superficial femoral artery(sfa) of diameter 5mm.The vessel was reported to be slightly tortuous.Embolic protection was not used.The device was prepped per ifu with no issues identified.The device did not pass through a previously deployed stent.An inflation device was used to inflate the balloon.It is reported that after deflating the balloon correctly, resistance was encountered, and the balloon would not go into the introducer.It was reported that the physician pulled on it a little to try release it.This caused the balloon to detach in the body of the patient.The detached portion was retrieved with a pair of pliers.It was reported there was no injury to the patient.

Manufacturer Narrative

Product analysis: the device was returned for analysis together with an introducer sheath.A visual and tactile inspection was performed on the device.The in.Pact admiral catheter was broken in two pieces and the breakage occurred at the proximal balloon welding.The shaft was still loaded on the guidewire but it was impossible to remove the guidewire because it was blocked into the guidewire channel.The balloon was unfolded and had blood on it.The balloon showed a deformation compatible with a withdrawal attempt before a complete deflation.The introducer sheath was damaged (kinked) in several parts.New info: updated event to include additional information: severely calcified lesion.Not all balloon fragments were retrieved.No additional treatment was required.Notified date: rep clarified notified date as (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional info: there is no balloon fragment in the patient's body.A non mdt introducer sheath was used.If information is provided in the future, a supplemental report will be issued.

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: 7533164
• MDR Text Key: 108886435
• Report Number: 9612164-2018-01191
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 10/03/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2020
• Device Catalogue Number: SBI05012008P
• Device Lot Number: 0008731544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 07/03/2018; 08/20/2018; 08/08/2018
• Supplement Dates FDA Received: 08/01/2018; 08/24/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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