MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

Model Number M001173010

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2015

Event Type  Injury  

Event Description

It was reported that balloon positioning/placement problem occurred.The patient who was post-cesarean, was losing a lot of blood and had elevated blood pressure; underwent postpartum hemorrhage embolization.Vascular access was obtained via the right common femoral artery.The target vessel was located in the aorta.A 6-6/2/80 occlusion balloon catheter was advanced to the bifurcation of the iliac.After measuring the aorta, the physician dilated the balloon until the distal aorta measured 11mm.After inflating the balloon, the physician noticed that the device would not stay in place.With every heart beat, the pressure exuded from the left ventricle into the aorta which pushed the balloon down.The physician believes that the balloon moved so much due to the shaft being far too soft.The procedure was completed with a different device.

Manufacturer Narrative

Date of birth: 1984.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: OCCLUSION BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4490225
• MDR Text Key: 19990531
• Report Number: 2134265-2015-00404
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K062202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001173010
• Device Catalogue Number: 17-301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other