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

Catalog Number SBI05015008P

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problems Rupture (2208); Patient Problem/Medical Problem (2688)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: the device was returned with the original pouch.A visual and a tactile inspection was carried out: the device was returned broken in three separate parts: luer with the shaft, that revealed a stretched portion in proximity of the welding; distal part of the balloon with a portion of the stretched underlying lumen; remaining part of the balloon with the tip.The tip was found damaged.Furthermore, dry blood and contrast agent was found on the device.The measured usable length of the returned device was 83.5 cm (the usable length foreseen in the lot release specifications for in.Pact admiral is 80 cm ± 2 cm).The device was flushed and an attempt to advance a 0.035¿ guide wire was performed, unsuccessfully: the guide wire got stuck in correspondence of the stretched portion of the shaft.

Event Description

The in.Pact admiral paclitaxel-eluting pta balloon was used to treat a calcified plaque lesion, with little calcification and moderate tortuosity, with 50% stenosis in the proximal mid superficial femoral artery.The artery diameter is 5mm, lesion length is 150mm.The balloon was inflated according to manufacturing specifications.Deflation time was relatively long due to repeated deflation methods.The balloon was completely deflated when using negative pressure, using suction of a 10ml syringe.The physician exchanged the sheath for a long 6fr to do the pta procedure unsuccessfully.There was no difficulty crossing the lesion with the in.Pact admiral, the balloon was completely deflated during the procedure.It was reported that difficulty was encountered removing the balloon from the sheath, the balloon and the sheath were removed together, resulting in a rupture to the common femoral artery, which required an open repair.It was reported that the patient has had a leg amputation post-procedure.It was reported that the amputation was not due to the procedure or use of the in.Pact admiral.The amputation was performed due to multiple stenosis.

• 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: 7077162
• MDR Text Key: 93555257
• Report Number: 9612164-2017-01699
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Report Date: 12/01/2017

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: 09/24/2019
• Device Catalogue Number: SBI05015008P
• Device Lot Number: 0008232365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2016
• 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): Required Intervention; Disability
• Patient Age: 69 YR