MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE ISP 6F CHRONOFLEX INTERMEDIATE NAUTILUS DELTA; SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	1606382
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A recall has been initiated for this product catalog/lot number combination.Investigation summary: the following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample evaluation, and applicable risk management documents.Based on a review of this information, the following was concluded: the complaint of inability to obtain an ecg waveform was inconclusive because the complete sample was not returned for evaluation.The product returned for evaluation was one nautilus delta lead.The leads assembly and flushing connector were not returned for evaluation.The alligator clip and tether assembly connections appeared unremarkable.Inspection of the sample using a digital multi tester did not reveal any discontinuities.The resistance was steady and remained so during sample manipulation.No deficiencies were discovered during evaluation of the returned sample; however, the leads assembly and the flushing connector could not be inspected, nor could their interface with the returned sample be assessed.Consequently this complaint is inconclusive at this time.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.
Event or Problem Description
It was reported during insertion of the isp clearvue nautilus port.The metal stem connector of the luer lock to the port catheter was scrubbed using a soaked 4x4 with sterile isopropyl alcohol.The alligator clip was attached and scoring method was performed, "scoring" the metal stem to improve conductivity.Despite these efforts no discernible wave form was established, "flatline".Fluoroscopy was obtained to verify the placement of the catheter.There was no reported patient injury.

• Brand Name: POWERPORT CLEARVUE ISP 6F CHRONOFLEX INTERMEDIATE NAUTILUS DELTA
• Common Device Name: SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7688181
• Report Number: 3006260740-2018-01722
• Device Sequence Number: 1398136
• Product Code: LJT
• UDI-Device Identifier: 00801741136719
• UDI-Public: (01)00801741136719
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Caregivers
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: 05/31/2018
• Device Model Number: 1606382
• Device Catalogue Number: 1606382
• Device Lot Number: REBR1147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 145