MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING, ELECTRODE CATHETER, STAINLESS STEEL ELECTRODES; BIPOLAR ELECTRODE CATHETER

Model Number 006173P

Device Problems Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the diameter of the bipolar electrode catheter was too big and would not fit into the sheath.

Event Description

It was reported that the diameter of the bipolar electrode catheter was too big and would not fit into the sheath.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿insertion instructions using a percutaneous introducer sheath".

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING, ELECTRODE CATHETER, STAINLESS STEEL ELECTRODES
• Type of Device: BIPOLAR ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8923254
• MDR Text Key: 155498395
• Report Number: 1018233-2019-05029
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1