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

Catalog Number PCE050040130

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the catheter was full of blood.The catheter returned broken with the distal part missing: the balloon with tip and the distal marker.Only the proximal part of the catheter with hub, shaft and the proximal marker still crimped on the guidewire tube returned.The detachment between balloon and shaft happened at the proximal balloon welding.Even with the distal part missing, it was possible to load the 0,018 guidewire from the hub.Image evaluation: two pictures were received showing the catheter in vitro after use.The device is dirty of blood and the balloon was not present.The distal marker was not visible.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a pacific plus with a non-medtronic 6f sheath and non-medtronic inflation device for the treatment of a moderately calcified non-tortuous lesion in the distal superficial femoral artery (sfa) following initial treatment of the occlusion using a non-mdt device.Device was prepped as per ifu without issue.The device did not pass through a previously deployed stent, no resistance was encountered during advancement but excessive force during withdrawal was reported.It is reported that a part of the balloon material was detached when the balloon catheter was removed from the introducer sheath.The physician attempted to retrieve the detached balloon material, unsuccessfully.Physician then attempted to push the material to the vessel wall, but it was already displaced to a side branch of the gluteal artery by the blood flow.The stenosis in the sfa was treated with 3 non-medtronic stents.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7510728
• MDR Text Key: 108144497
• Report Number: 9612164-2018-01064
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Catalogue Number: PCE050040130
• Device Lot Number: 214988234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73