MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; PACING CATHETER

Model Number 006173P

Device Problems Accessory Incompatible (1004); Failure to Advance (2524)

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 catheters did not advance through the 5f sheaths.

Event Description

It was reported that the catheters did not advance through the 5f sheaths.

Manufacturer Narrative

The reported event was confirmed.The device was attempted to be passed through a french gauge.It could not pass through the 5 french hole but passed easily through the 6 french hole.A 10 cc luer lock syringe was used to fill the balloon with 5cc of air.The device was allowed to sit for a minute and deflate with no issues.A potential root cause is the device was manufactured with incorrect dimensions or material selected, or incorrect components supplied to user.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "read this document in its entirety prior to use.Single use.Sterile, non-pyrogenic store in a cool, dry place.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Description bard® temporary pacing catheters are constructed of a woven or extruded polyurethane shaft with platinum or stainless steel electrodes.Certain catheters may incorporate one or more lumens for fluid infusion, pressure monitoring, blood sampling, or balloon inflation.The balloons are manufactured using latex material.Some product may be packaged with accessories such as a needle cannula, safety lead adapter, an ecg adapter, or a balloon inflation syringe.Indications for use bard® temporary pacing catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.When an internal lumen is present (other than the one used for balloon inflation), it may be used for fluid infusion, pressure monitoring, or blood sampling.Contraindications none." corrections: d10, h3.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Type of Device: PACING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8650836
• MDR Text Key: 146486393
• Report Number: 1018233-2019-02790
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFCU2817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1