MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. POWERPORT MRI ISP, 8 FR GROSH, INTER W/O SUT. PLUG, S/L; IMPLANTABLE PORT

Model Number	1808561
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.One introducer sheath and corresponding dilator were returned for evaluation.The dilator was returned inserted into the sheath.The distal tip of both the sheath and dilator appeared to be damaged, with both appearing to curl outward.Based on this finding, the investigation is confirmed for the introducer damage, specifically damage to the introducer sheath and dilator.It is likely that the damage to the sheath and the damage to the dilator both occurred as a result of the same failure, which likely occurred during insertion per the reported event details.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Potential contributing factors include insertion technique, steep insertion angle and insufficient sized skin nick.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 1808561 implantable port during port device implant, when advancing, the tip of the dilator allegedly curled up.It was further reported that a new port device was used to complete the procedure.This report was received from one source.This event involved one patient with no reported patient injury.Patient age, weight, and gender not provided.

• Brand Name: POWERPORT MRI ISP, 8 FR GROSH, INTER W/O SUT. PLUG, S/L
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• MDR Report Key: 8532608
• Report Number: 3006260740-2019-01063
• Device Sequence Number: 11129210
• Product Code: LJT
• UDI-Device Identifier: 00801741027123
• UDI-Public: (01)00801741027123
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: No Information
• Device Model Number: 1808561
• Device Catalogue Number: 1808561
• Device Lot Number: RECW0362
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1