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

Model Number 006173P

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  Injury  

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 customer mentioned about material rupture , detachment of device or device component and failure to capture issues in the temporary pacing electrode catheter.It was stated that there were no clinical signs symptoms or conditions, but there was a surgical intervention.

Event Description

It was reported that the customer mentioned about material rupture, detachment of device or device component and failure to capture issues in the temporary pacing electrode catheter.It was stated that there were no clinical signs symptoms or conditions, but there was a surgical intervention.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that the customer mentioned about material rupture , detachment of device or device component and failure to capture issues in the temporary pacing electrode catheter.It was stated that there were no clinical signs symptoms or conditions, but there was a surgical intervention.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned for evaluation and further evaluation was not conclusive.Although a specific cause cannot be determined, based on the risk document a potential root cause for this event could be, "high modulus latex, non-uniform thin sac, exposure to degrading material".No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "this device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing." "do not inflate balloon beyond stated maximum inflation capacity of 1.5 ml." "when using a balloon catheter, use care when removing the protective sleeve from the distal portion of the catheter.Forced removal of this protective sleeve may result in damage to the balloon and the catheters structural integrity." "in case of catheters with a balloon, under sterile conditions, remove the protective sheath and inflate the balloon with 1.5 ml of air or carbon dioxide.Use the inflation syringe included in the package.Completely deflate the balloon after the test." corrections: b,f,g,h h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Type of Device: BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15445933
• MDR Text Key: 303955985
• Report Number: 1018233-2022-07233
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFFZ2111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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; Other