MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0607530

Device Problems Fracture (1260); Difficult to Remove (1528); Stretched (1601); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 10/2022).

Event Description

It was reported that during port placement procedure, the needle allegedly had difficulty to remove and it hooked with guidewire.It was further reported that physician had to force to withdraw the needle, the guidewire became frayed.Reportedly physician suspected that fragment remained in the vessel but nothing was observed on fluorescence control.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: 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.Investigation summary: one guidewire inserted into an introducer needle was returned for evaluation.Visual, microscopic visual, functional and dimensional evaluation were performed.The investigation is confirmed for the reported deformation due to compressive stress and identified fracture and stretched issue, as uncoiling of the outer coil was noted proximal to the introducer needle hub, protruding and a complete break was noted on the flat inner core wire.The investigation is inconclusive for the reported difficult to remove as the exact circumstances at the time of the reported event are unknown and the reported event was not abled to be reproduced in the lab.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the x-port isp implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the x-port isp implantable port, chronoflex single-lumen, kit, 6f products is identified in d2 and g4.H10: d4 (expiry date: 10/2022).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.H3 other text : see h10.

Event Description

It was reported that during port placement procedure, the needle allegedly had difficulty to remove and it hooked with guidewire.It was further reported that physician had to force to withdraw the needle, the guidewire became frayed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11778026
• MDR Text Key: 252358007
• Report Number: 3006260740-2021-01669
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026171
• UDI-Public: (01)00801741026171
• Combination Product (y/n): N
• PMA/PMN Number: K022983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 0607530
• Device Catalogue Number: 0607530CE
• Device Lot Number: REEV0327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR