MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 4FR 110CM; ELECTRODE CATHETER

Model Number	006172P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the balloon on the electrode catheter would not stay inflated.
Event or Problem Description
It was reported that the balloon on the electrode catheter would not stay inflated.
Additional Manufacturer Narrative
The reported event was confirmed, but the cause is unknown.The evaluation of the returned sample showed that when the device was inflated and submerged in water, the unit leaked out of the distal leg directly by the molded bifurcate (black box).The molded bifurcate was cross sectioned and no voids were detected.The device failed to meet specifications.The device was being used for treatment.A potential root cause of the reported event could be that the lumen was not properly seated due to which there was leak at the bifurcate, resulting in failure to inflate.This product is 100% inspected for product integrity, during the manufacturing process for inflated balloon diameter, balloon symmetry and for any visual defects to the balloon.The root cause could be manufacturing related but there was no way to determine the exact root cause.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: ¿warnings: do not inflate balloon beyond stated maximum inflation capacity of 1.5 ml.Balloon must be completely deflated before withdrawal of the electrode catheter.Precaution: 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.Instructions for use: 3.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.7.Using the aid of fluoroscopy or an ecg monitor, advance the catheter through the cannula to the desired position.If using a balloon catheter, inflate the balloon when the catheter is in the right atrium.Please note that the balloon can be inflated or deflated only when the stopcock is parallel to the catheter shaft.Do not pull the catheter back through the cannula as it may cause damage to the catheter.".
Event or Problem Description
It was reported that the balloon on the electrode catheter would not stay inflated.
Additional Manufacturer Narrative
The reported event was confirmed, but the cause is unknown.The evaluation of the returned sample showed that when the device was inflated and submerged in water, the unit leaked out of the distal leg directly by the molded bifurcate (black box).The molded bifurcate was cross sectioned and no voids were detected.The device failed to meet specifications.The device was being used for treatment.A potential root cause of the reported event could be that the lumen was not properly seated due to which there was leak at the bifurcate, resulting in failure to inflate.This product is 100% inspected for product integrity, during the manufacturing process for inflated balloon diameter, balloon symmetry and for any visual defects to the balloon.The root cause could be manufacturing related but there was no way to determine the exact root cause.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: ¿warnings: do not inflate balloon beyond stated maximum inflation capacity of 1.5 ml.Balloon must be completely deflated before withdrawal of the electrode catheter.Precaution: 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.Instructions for use: 3.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.7.Using the aid of fluoroscopy or an ecg monitor, advance the catheter through the cannula to the desired position.If using a balloon catheter, inflate the balloon when the catheter is in the right atrium.Please note that the balloon can be inflated or deflated only when the stopcock is parallel to the catheter shaft.Do not pull the catheter back through the cannula as it may cause damage to the catheter." 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, 4FR 110CM
• Common Device Name: ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9252104
• Report Number: 1018233-2019-06906
• Device Sequence Number: 11511465
• Product Code: LDF
• UDI-Device Identifier: 00801741011191
• UDI-Public: (01)00801741011191
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 006172P
• Device Catalogue Number: 006172P
• Device Lot Number: GFDR0499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 02/04/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/19/2019; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1