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

Model Number ADM06006013P

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used an inpact admiral drug coated balloon with a 6fr non-medtronic sheath and non-medtronic guidewire during treatment of a 40mm plaque lesion in the patient¿s proximal left superficial femoral artery, posterior tibial artery, and anterior tibial artery.Artery diameter reported as 6mm.Slight vessel calcification reported.Severe iliacs tortuosity ,almost 90 degree common -external iliac connection reported related to the patient¿s anatomy.Lesion exhibited 70% stenosis.A non-medtronic inflation device as used with 50/50 inflation fluid for balloon inflation.There was no damage noted to the packaging.No issues were noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.Medium resistance was noted when advancing the balloon into the 6fr sheath on right groin up and over and delivering it to the left proximal left sfa.The left iliacs were almost shaped in two right angles.The physician applied excessive force to push the balloon forward.Post dilation the physician began pulling the balloon back into the sheath placed in the left common femoral artery.The balloon stopped moving backward when it was halfway into the sheath.The physician made several manoeuvres forward and backward but failed to get the entire balloon into the sheath and subsequently decided to pull the sheath (and half of balloon catheter into it) back, to remove from left iliacs.A break on the catheter is reported.The sheath became stuck at the aortic bifurcation despite several manoeuvres to remove.The physician then advanced a non-medtronic wire up to the aortic arch and watched balloon the part moving up as well as the wire does.The physician pulled balloon catheter back again over that wire, but it was not moving.The physician then gained access and the left groin with an 6fr sheath and primarily used a gooseneck snare to externalise the wire tip but failed.There was no crossing/positioning difficulty with this snare.The physician then moved on to the snare the broken part of the balloon which was successfully captured and brought down to the bifurcation level where the left 8fr sheath tip was located.The physician could not remove the broken part of the balloon but could hold it in place.The right groin sheath was changed to 9f and the wire and balloon were pulled back and removed together from the body.A second gooseneck snare was used from the right groin to snare the free tip of the balloon catheter part which was held at the bifurcation and removed through the right 9fr sheath.The patient is reported to be doing perfect.No further injury reported.

Manufacturer Narrative

Product analysis: the device was returned for analysis.The device was decontaminated with cidex opa solution soak and tergazyme soak pending further device testing to support the final product analysis findings.The device returned with a detachment to the shaft approximately 39cm proximal to the distal tip with the material deformed and jagged at both sides of the detachment site.The shaft was stretched at multiple locations on the catheter.The balloon folds were open.A non-medtronic guidewire returned entrapped in the device.A tactile test detected a kink to the balloon and inner member at the same location.Lumen patency was unable to be tested due to the entrapment of the non-medtronic guidewire.The balloon was unable to be inflated due to the detachment and deflation testing also could not be performed.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11617755
• MDR Text Key: 243936686
• Report Number: 9612164-2021-01311
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169383265
• UDI-Public: 00643169383265
• 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
• Report Date: 09/14/2021

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: 09/10/2023
• Device Model Number: ADM06006013P
• Device Catalogue Number: ADM06006013P
• Device Lot Number: 0010373313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 07/26/2021; 09/02/2021
• Supplement Dates FDA Received: 07/27/2021; 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 118