MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F CHRONOFLEX OPEN-ENDED SING; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607510
Medical Device Problem Codes	Component Incompatible (1108); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 that the guide wire stuck during insertion.There was no reported patient injury.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Upon receiving additional information, this event was reassessed and determined to be not mdr reportable.However, an initial mdr has already been submitted; therefore, the purpose of this supplemental report is to document the change in reportability classification.
Event or Problem Description
It was reported that the guidewire was stuck in the device during insertion.A new device was used to complete the procedure.There was no reported patient injury.

• Brand Name: X-PORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F CHRONOFLEX OPEN-ENDED SING
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7939042
• Report Number: 3006260740-2018-02753
• Device Sequence Number: 1665037
• Product Code: LJT
• UDI-Device Identifier: 00801741026157
• UDI-Public: (01)00801741026157
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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 Model Number: 0607510
• Device Catalogue Number: 0607510
• Device Lot Number: REBU2342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1