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

Catalog Number PCE020150130

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a pacific plus pta balloon during treatment of a calcified lesion in the patient¿s mid superficial femoral artery (sfa).Lesion exhibited 70% stenosis.No tortuosity, slight calcification of the vessel reported.Ifu was followed.Device prepped without issue.Embolic protection was not used.A syringe was used or balloon inflation.The balloon was not passed through a previously deployed stent.Resistance was encountered when advancing the device, but no excessive force was used.There is a report of ¿flushing cavity bleeding¿.This is a suspected leak on the balloon.The device was replaced with another pta balloon to complete the procedure.No patient injury reported.

Manufacturer Narrative

Product analysis: the pacific plus pta catheter was received for evaluation.Sanguine residue was noted in the guidewire lumen of the y-manifold.A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed: sanguine tinted fluid was observed exiting the distal tip of the pta catheter.The guidewire lumen was flushed until clear fluid was observed exiting the distal tip of the catheter.A 0.018¿ guidewire was loaded through the distal tip and navigated out the proximal luer lock with ease.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold and a vacuum could be pulled but not maintained; indicating communication between the inflation lumen and the environment, (e.G.Leak).The syringe was pressurized and a pinhole leak in the catheter was noted approximately 69.5cm proximal from the distal tip of the pta catheter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC PLUS
• 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: 8939211
• MDR Text Key: 155792398
• Report Number: 9612164-2019-03615
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: PCE020150130
• Device Lot Number: 217224647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2019
• 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: 73 YR