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

Model Number M001173010

Device Problem Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12581.It was reported that the balloons ruptured and the patient required surgery.The patient presented with bilateral artery occlusion and placenta previa.Two 6-6/2/80 occlusion balloon catheters were advanced into the left and right femoral artery for dilation.No resistance was noted upon inserting the balloon and no imaging was performed as the patient was pregnant.The balloons were inflated to 2 atmospheres and the pressure immediately dropped.The patient was then successfully operated for the delivery of the baby and the balloon catheters were also removed.Upon removal, it was noted that the balloons were split.After the balloons were removed, the patient had a big bleed which prompted an emergency hysterectomy and the patient was on "hdu." no further patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the unit returned has balloon damaged, as part of overall visual revision.The balloon is burst.The catheter of the device is kinked approximately at 14.5 cm from the balloon hub, close to the bifurcation.Functional testing cannot be performed based on the returned condition of the balloon.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was further reported that imaging to aid in placement of the occlusion balloons was performed with image intensifier.The balloons were being used to occlude the internal iliac arteries, to provide an a-vascular field for a high risk c-section.The balloons were inflated once before they ruptured.In the opinion of the physician the balloons were not related to the report of "big bleed." the balloons were successfully removed following the c-section.The patient was on a high dependency unit following the procedure.The patient and baby are healthy.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7158473
• MDR Text Key: 96185107
• Report Number: 2134265-2017-12582
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2018
• Device Model Number: M001173010
• Device Catalogue Number: 17-301
• Device Lot Number: 20700531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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): Required Intervention
• Patient Age: 44 YR