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

Model Number PCU060300130

Device Problems Deflation Problem (1149); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Fistula (1862); Vascular Dissection (3160)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a pacific xtreme pta balloon catheter along with non-medtronic 7fr sheath and 0.014" 300cm guidewire during procedure to treat a little calcified plaque lesion in the mid to distal popliteal artery.The vessel diameter and lesion length are 6mm and 100mm respectively.A medtronic inflation device was used for balloon inflation.Inflation fluid used was a contrast 30% and saline70% solution.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.Balloon deflation difficulties was reported.The deflation issue was noted during subsequent inflation.During withdrawal back into sheath, the catheter broke and the detached piece was removed with a snare.The device passed through a previously deployed stent.No resistance was encountered when advancing the device.More balloons and stents were needed to complete the procedure as a result of the balloon issue.It was reported that the balloon was used to pre dilate the lesion before stenting with a 6mm non-medtronic stent, then also used to post dilate the stent.After the post dilation inflation, the balloon would not deflate.The physician debated puncturing the balloon with a needle percutaneously in order to deflate the balloon, but before that was done, it was noticed that with steady gentle traction against the sheath tip, the balloon was slowing deflating.It was during this process that the catheter shaft broke.Physician snared the retained piece of the balloon and catheter.After snaring, it was noticed that the distal end of the stent was now deformed and a dissection had extended through the popliteal to the tibial/popliteal trunk (tpt) arteries.Multiple balloon inflations and additional stenting was performed to help correct this and improve flow.The patient also developed an av fistula in the tpt.This was relatively slow flow initially but increased quite dramatically over the following 24 hours and ultimately had to be repaired with a covered stent the day after index procedure.Physician reported that the issue with this balloon caused a cascade of additional work that needed to be performed on the patient.A dissection of the popliteal and tpt arteries that require further intervention and stenting.Patient injury of vessel damage and dissection occurred.

Manufacturer Narrative

Additional information: the patient is currently doing fine.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

Product analysis: the pacific xtreme device was returned to medtronic investigation lab for analysis.The device was returned coiled in a shelf carton in a biohazard bag.The pacific xtreme pta balloon catheter returned detached at the center of the balloon with a non-medtronic 7fr sheath and a non-medtronic 0.014¿ guidewire.The non-medtronic guidewire was loaded through the distal end of the proximal detached balloon segment.The distal portion of the detached balloon returned partially inside the 7fr sheath and a snare is visible coming out of the proximal end of the sheath.The detachment is approximately 117mm distal from proximal balloon bond.Snare moved by hand and is visible at the distal end of sheath attached to detached distal balloon portion.Proximal and distal balloon marker bands visible and intact.Stretching visible along inner distal to proximal marker band.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, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10866197
• MDR Text Key: 217090934
• Report Number: 9612164-2020-04470
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08033477075891
• UDI-Public: 08033477075891
• Combination Product (y/n): N
• PMA/PMN Number: K103464
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2023
• Device Model Number: PCU060300130
• Device Catalogue Number: PCU060300130
• Device Lot Number: 220526894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2020
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention