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

Catalog Number PCE020120130

Device Problem Burst Container or Vessel (1074)

Patient Problems Rupture (2208); Patient Problem/Medical Problem (2688)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use a pacific plus pta balloon to treat a calcified, moderately tortuous calcified lesion in the proximal radial artery.There was no issue when the product was taken out of the package or tray.The device was prepped without issue.No embolic protection was used.The device was inflated with a syringe.The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion.When the device was inflated to 4atm at the lesion site, the balloon burst causing the vessel to rupture.The patient had to have surgery and ligation to stop the bleeding.There was no further treatment given.

Manufacturer Narrative

All device components were removed from the patient.The patient is reported to be doing good.The patient is to be rescheduled for additional treatment.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.

• 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: 8767023
• MDR Text Key: 150245465
• Report Number: 9612164-2019-02739
• 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,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2022
• Device Catalogue Number: PCE020120130
• Device Lot Number: 217473345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• Date Device Manufactured: 04/08/2019
• 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: 66 YR