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

Catalog Number PCE050120090

Device Problems Leak/Splash (1354); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use pacific plus pta balloon along with non-medtronic 5fr sheath and 0. 014" guidewire during procedure to treat a little calcified soft tissue lesion in the left mid popliteal artery with 60% stenosis. The vessel was none tortuous. The vessel diameter and lesion length are 4. 8mm and 115mm respectively. No embolic protection was used. A non-medtronic inflation device was used for balloon inflation. Visipaque 320 was used for inflation fluid. Thee was no damage noted to packaging. There was an issue noted when removing device from hoop/tray. It was reported that physician noted when removing balloon out of the hoop that the mandrel is still in place, when mandrel was removed, it was noted that the balloon was bent. The product was damaged out of the package. Physician decided to try and use the balloon and could advance the balloon to the lesion site with no effort. When balloon was inflated, it was noted that contrast leaked out of the proximal balloon attachment site, where the issue was noted. The device was flushed per ifu with no problem noted. During inflation, leak was noted at the transition shaft. All fragments of the balloon was retrieved. The device passed through a previously deployed stent. No resistance encountered when advancing or removing the device. The device was removed and a non-medtronic dcb was used to complete the procedure. There was no patient injury.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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 ; EI ; 091708734
• MDR Report Key: 11250968
• MDR Text Key: 229338082
• Report Number: 9612164-2021-00386
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/08/2021
• Device Catalogue Number: PCE050120090
• Device Lot Number: 215416853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial