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

Model Number PCU070200130

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a pacific xtreme pta balloon during treatment of a 200mm fibrous lesion in the patient¿s distal right superficial femoral artery (sfa) and popliteal artery.Slight vessel tortuosity and moderate calcification are reported.Vessel diameter is reported 7mm.Lesion exhibited 80% stenosis.No damage noted to product packaging prior to use.No issues noted wen removing the device from the packaging.A 7fr non-medtronic sheath and nitrex wire were used.Ifu was followed and the device was prepped without issue.An inflation device with 50/50 inflation fluid was used.The device was passed through a previously deployed stent no resistance was encountered.It is reported when inflating the balloon at the lesion site at a pressure of 4atm a twist was noted.A rewrap issue was noted.The balloon was removed, and a second pacific xtreme was advanced the same way.Two twists were observed on the second balloon.The balloon was removed, and the procedure was completed using a nanocross balloon.No patient injury reported.

Manufacturer Narrative

Additional information: the device was fully deflated prior to the device being safely removed from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: two procedural photographs of cine images were received.Both images are just above the right knee in the patient¿s distal superficial femoral artery and popliteal artery.The first image includes a pta just distal of a deployed stent.A guidewire is visible within the inflated balloon.The guidewire undulates within the balloon chamber.Two balloon twists ¿candy wrapping¿ is visible in the images.The balloon twists appear to be between 4cm and 5cm apart.The second image includes a pta just distal of a deployed stent.A guidewire is visible within the inflated balloon.The guidewire undulates within the balloon chamber.Two balloon twists ¿candy wrapping¿ is visible in the images.The balloon twists appear to be between 6cm and 8cm apart.Product analysis: the pacific xtreme pta balloon catheter was received within a zippered closure plastic pouch, along with a tyvek pouch, and loosely coiled within opened shelf carton.The lot number information printed on the y-manifold is consistent with the data on the shelf carton label and reported event.The pacific xtreme catheter was received with the balloon chamber in a post-inflation profile, (e.G.Not tightly wrapped or winged).Dried sanguine residue was noted on the exterior of the pacific xtreme.A kink in the catheter was noted just distal of the green y-manifold strain relief.A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed: a clear steady stream of fluid was observed exiting the distal tip of the catheter.A 0.018¿ guidewire was loaded through the distal tip of the catheter with ease and would only navigate as far as the kink in the catheter at the distal tip of the y-manifold green strain relief.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold and the balloon chamber was lightly inflated.A balloon chamber material balloon twist witness mark was noted approximately 40mm from the balloon¿s proximal radiopaque marker band.A second balloon twist witness mark was noted approximately 126mm from the balloon¿s proximal radiopaque 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: 9774115
• MDR Text Key: 182995071
• Report Number: 9612164-2020-00955
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08033477075938
• UDI-Public: 08033477075938
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: PCU070200130
• Device Catalogue Number: PCU070200130
• Device Lot Number: 218557811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1