MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT PACIFIC; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number PCF05012013P

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Hematoma (1884)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use an inpact pacific paclitaxel eluting balloon catheter along with non-medtronic 5fr 45cm sheath and 0.018" guidewire during procedure to treat instent restenosis in the superficial femoral artery (sfa).No embolic protection was used.There was no damage to packaging.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that pre dilatation went well.Physician then decided to use inpact pacific dcb, but there was a problem as balloon was inflated with contrast as it was not good visible.The contrast medium was a mixture of 50% water and 50% ultravist.Air/gaseous medium was not used for balloon inflation.It was not possible to deflate the inpact pacific.Physician then pulled it out without deflation.Hematoma occurred with the incision bigger than usual.The hematoma was treated according to the hospital's protocol of compression for 45 minutes, consisting of compress and immobilization.The physician pulled the sheath and inpact pacific out of the patient.No further injury reported.

Manufacturer Narrative

Product analysis: the inpact pacific device was received into the medtronic investigation lab for analysis.The device was returned in an introducer sheath.Approximately 91cm of the shaft of the device returned exterior to the introducer sheath (proximally).Approximately 3cm of the working length of the balloon was distal to the distal tip of the introducer sheath.This section of the balloon was filled with air.There was a kink to the shaft approximately 3.5cm distal to distal hub.There were two squashes to the shaft between 81 ¿ 89cm distal to the distal hub.Significant stretching and damage were evident to the shaft of the complaint device immediately proximal to the balloon.The balloon was removed from the sheath (distally).The balloon folds were open.Liquid was present in the proximal and mid balloon (returned in the sheath), measuring approximately 9cm of the length of the balloon.Slight damage was present to the distal tip, consistent with use of the device.Kinks were present on the shaft of the introducer sheath approximately 2mm and 22cm distal to the distal sheath hub.A 0.018 inch guidewire was loaded via the distal tip but was unable to be advanced due to the damage sustained to the device.Negative pressure did not deflate the balloon and no leaks were present.It was not possible to remove the device proximally through the sheath.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

Image review: images provided were not time stamped therefore an accurate sequential description of events cannot be derived.The images provided show the attempted inflation of a balloon within an implanted stent in the superficial femoral artery (sfa).Significant obstruction of blood flow is present seemingly prior to treatment.During balloon inflation contrast is visible in a relatively small section of the balloon.Contrast does not appear to be present in the distal section of the balloon despite the balloon being inflated.Images show the balloon in an identical condition within the distal and proximal portions of the implanted stent lending to the report of removal of the device prior to balloon deflation.There is evidence of improved blood flow post procedure.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 PACIFIC
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11235162
• MDR Text Key: 228871668
• Report Number: 9612164-2021-00331
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Catalogue Number: PCF05012013P
• Device Lot Number: 0010436308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1