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

Catalog Number PCE060060090

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

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 during treatment of a 60mm, 70% stenosed soft tissue lesion in mid/proximal/distal location at the av shunt.It is reported ifu was followed and the device was prepped without issue.A medtronic inflation device was used.The device was not passed through a previously deployed stent.It is reported that during inflation of the balloon, the inflation was not complete, and contrast was observed to be leaking from the balloon catheter.Small holes were observed on the shaft of the balloon proximal to the where the contrast was leaking from.Procedure completed normally.No patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: model of medtronic inflation device is not known.The procedure was completed using a new pacific plus device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the videos provided showed a leak both in vivo and in vitro.The images show balloon inflation and leak at the shaft distal part, near the balloon.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; 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: 7684815
• MDR Text Key: 114540759
• Report Number: 9612164-2018-01723
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Catalogue Number: PCE060060090
• Device Lot Number: 214767474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2018
• Date Device Manufactured: 01/22/2018
• 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 Age: 55 YR
• Patient Weight: 58