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

Catalog Number PCF06012009P

Device Problems Fracture (1260); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician attempted to use a in.Pact pacific for patient treatment of the left proximal superficial femoral artery (sfa).The calcified lesion had no degree of tortuosity and little degree of calcification.A 0.018 guidewire was used.Ifu was followed.No damage was noted to the device packaging and no issues noted when removing the device from hoop/tray.It was reported that the balloon broke/fractured during delivery through the vessel.No resistance was encountered when advancing the device and no excessive force was used.Device not passed through a previously deployed stent.The balloon was able to be inserted; however, upon positioning the balloon to the proximal lesion, the balloon was unable to be pushed through.The physician pulled out the device and saw that an area of the balloon had a cracked portion.No inflation was conducted with the balloon.The balloon is not inflated at all.No component detached from the balloon.No intervention was required for removal.Another device was used to complete the procedure.No patient injury was reported.

Manufacturer Narrative

Image review: one image was provided for technical analysis.The image shows the balloon and a section of the shaft of the complaint device at the account.The balloon folds appear closed.Blood is present on the surface of the balloon and/or inside the lumen.There is no damage evident to the device.The image does not support the reported ¿crack¿ to the balloon.Product analysis: the inpact pacific device was returned to medtronic investigation lab for evaluation.The device was returned with deformation to the shaft approximately 47-48cm distal to the distal strain relief.Damage was evident to the inner member at two sites at the balloon, approximately 2cm and 7cm proximal to distal marker band.A tear was evident to the guidewire lumen approximately 46cm distal to the distal strain relief.Slight deformation was present to the distal tip consistent with use of the device.The balloon folds were closed.A tactile test did not detect any other abnormalities along the length of the catheter or balloon.A 0.018inch guidewire was loaded via the distal tip with resistance noted due to the damage to the inner member and guidewire lumen.Negative prep detected a leak to the device.The balloon was inflated but was unable to hold pressure with fluid escaping from the tip and guidewire entry port at the luer.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 ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12340788
• MDR Text Key: 267215179
• Report Number: 9612164-2021-03193
• 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
• Report Date: 09/29/2021

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: 10/02/2021
• Device Catalogue Number: PCF06012009P
• Device Lot Number: 0009356396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1