MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 TEMPORARY PACING ELECTRODE CATHETER

Model Number	106173P
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
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.The device was not returned.
Event or Problem Description
It was reported that the temporary pacing electrode catheter had defective pacing or spacing wires.
Event or Problem Description
It was reported that the temporary pacing electrode catheter had defective pacing or spacing wires.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.It was unknown whether the device had met relevant specifications.The product can be used for diagnostic and treatment purposes.It was unknown what purpose the product was used for.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be operator error.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "precautions ¿ excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.¿ 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.¿ for non heparin bonded catheters only: when wiping down this catheter, use only sterile saline.¿ for those catheters that are heparin bonded, the following precautions apply: anticoagulant bonding: since the surface of the catheter shaft is treated with a heparin bonding, do not wipe the shaft with alcohol, its esters or ethers, or phenol compounds lest the bonding be rubbed off.If wound closure is prolonged, an appropriate topical hemostatic agent should be used to neutralize the effect of any heparin that may have been wiped off at the edge of the wound.Longer compression time at the insertion site may be required.The packaging is designed to avoid crushing of the catheter and to help protect the heparin bonding on the surface of the catheter.The heparin treated surfaces are fragile.As a result, reasonable care should be employed when removing the catheter from the package." h11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.

• Brand Name: TEMPORARY PACING ELECTRODE CATHETER
• Common Device Name: TEMPORARY PACING 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11712093
• Report Number: 1018233-2021-02307
• Device Sequence Number: 14514151
• Product Code: LDF
• UDI-Device Identifier: 00801741011573
• UDI-Public: (01)00801741011573
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: Lay User/Patient
• Device Model Number: 106173P
• Device Catalogue Number: 106173P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown