MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number PCF050250090

Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

Physician was attempting to use the pacific xtreme balloon during procedure to treat moderately calcified plaque in the mid superficial femoral artery.The vessel had moderate tortuosity and exhibited cto (chronic total occlusion-100%).The balloon was inflated with a syringe.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.It was reported that there were balloon inflation difficulties during inflation.A balloon twist occurred and rewrap issue was noted.A rewrap tool was not used.The ¿twist¿ was noted at around 6 atm and the balloon was deflated in the usual way and reinflated after repositioning more distally to exclude the possibility of a focal stenos is that prevented the balloon from deploying totally.The problem occurred again with the twist seem at the same site in the balloon and a different site with respect to the artery.No specific measures were taken to deflate the balloon and deflation time was within the normal range.The device was safely removed from the patient with no complications encountered.The procedure was completed by deploying the device and using another non-medtronic product.No patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis a visual inspection of the balloon found a twist in the middle of the balloon approximately 7.5cm the balloon bond a 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip 0.018¿ guidewire was loaded through the tip and exited at the luer an indeflator with pressure gauge was used to inflate the balloon to nominal pressure of 6 atms and the balloon inflated with no twist evident, (photo 8).The balloon was inflated to rated burst pressure of 14 atms with no twist evident the balloon was deflated without issue with slight twist evident 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: PACIFIC XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13900228
• MDR Text Key: 289457380
• Report Number: 9612164-2022-01170
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PCF050250090
• Device Lot Number: 222073744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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 Sex: Male