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

Catalog Number PCF040250090

Device Problem Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

Image analysis: two photographs of cine images were received.The first image is of the inflated pacific xtreme inflated in the patient¿s mid right superficial femoral artery, towards the bottom of the image a section of the balloon is twisted ¿candy wrap¿.The second image is of the inflated pacific xtreme inflated in the patient¿s mid right superficial femoral artery, towards the top of the image a section of the balloon is twisted ¿candy wrap¿.The customer experience of the pacific xtreme balloon twisting when inflated in the targeted vessel anatomy was confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a pacific xtreme device during treatment of a calcified/plaque lesion in the patients mid right superficial femoral artery (sfa).No tortuousity is reported.Moderate calcification is reported.The lesion exhibited 70% stenosis.Ifu was followed and the device was prepped without issue.An inflation device was used for balloon inflation.It was reported that a 'candy wrap' effect was noted.Due to experience the physician successfully completed the procedure using this device without any inconvenience to the patient.

Manufacturer Narrative

Device evaluation: the pacific xtreme was received within its shelf carton, within its opened labelled pouch, and loaded within its protective transportation hoop.The lot data information printed on the y-manifold is consistent with the lot number on the pouch, shelf carton, and reported event.Visual examination of the balloon chamber revealed ¿balloon twist¿ witness marks in the balloon chamber material.The ¿candy wrapper¿ ¿balloon twist¿ are located approximately 45mm and 80mm distal of the proximal balloon marker band.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Cine image review: images 1 and 2 appear to be from the same case and involve an implanted stent.The lesion proximal (towards the heart) to the stent appears to be tortuous and calcified.Image 3 has an arrow annotating the location of a balloon twist ¿candy wrapper¿.A stent is visible in the bottom third of the of the image and a guidewire runs the length of the image.Image 4 appears to be from the original case and has two arrows annotating the location of a balloon twist ¿candy wrappers¿.A guidewire runs the length of the image.Image 5 appears to be from the original case in this cine the pta balloon catheter appears to be fully inflated without balloon twists ¿candy wrappers¿.A guidewire runs the length of the image.Image 6 appears to have multiple stents deployed, at least three stents with two of them over lapping at the bottom of the cine.Images 7 and 8 appear to be from another case based on the anatomy land marks and may involve a drug eluting balloon based on the annotation at the top of the image.Analytical analysis of the additional cine received confirms the original analysis and investigation conducted.No changes to the findings or codes of the original analysis and investigation.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
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8882968
• MDR Text Key: 153955300
• Report Number: 9612164-2019-03329
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: PCF040250090
• Device Lot Number: 213411573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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 Age: 77 YR