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

Catalog Number ADM05025013P

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician used an inpact admiral balloon catheter to treat a soft tissue lesion of severe tortuosity and moderate calcification of the left distal superficial femoral artery.Chronic total occlusion-100% was reported.The artery diameter was 5mm and the lesion length was 300 mm.There were abnormalities reported in relation to anatomy, tortuous iliacs treated with crossover sheath from the rcfa.A 6 f non-medtronic sheath and 0.014 5mm guidewire were used.A spiderfx 5mm was used for embolic protection.Inflation fluid and an inflation device of unknown make and model were used.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu, with no issues identified.The device did not pass through a previously-deployed stent.It is unknown if resistance was encountered when advancing the de vice.It is unknown if excessive force used.It was reported that when removing the balloon from the body post dilatation, a break/fracture occurred at balloon.The detached portion of device does not remain in patient, it was removed with the sheath while it was inside the sheath.The persisting sheath and broken balloon were removed, a new crossover sheath was placed and the procedure was c ompleted.There were no patient symptoms or complications associated with this event.

Manufacturer Narrative

Product analysis: the device was received for evaluation.The device was decontaminated with cidex-opa and tergazyme soak pending further testing to support the final product analysis findings.The device returned with a detachment evident on the catheter approximately 16.5cm proximal to balloon bond.The catheter was severely stretched proximal to the detachment site.The catheter at the detachment site was stretched, jagged and uneven.The balloon returned with blood and residue evident inside the balloon material.A kink/deformation was evident on the balloon material approximately 10.2cm proximal to the balloon bond.Mid-to-distal balloon material and balloon folds appear more expanded.Slight traces of residue were evident in the mid-to-distal balloon material.Deformation was evident to the distal tip.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.

Manufacturer Narrative

Additional information: no resistance was encountered when advancing the device.The issue occurred within the patient.No vessel damage was noted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 10612220
• MDR Text Key: 209360557
• Report Number: 9612164-2020-03721
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Catalogue Number: ADM05025013P
• Device Lot Number: 0010204071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 10/30/2020; 11/06/2020
• Supplement Dates FDA Received: 10/19/2020; 11/05/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR