MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 7707540J

Device Problems Fracture (1260); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f are identified.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during a port device placement procedure, the guidewire was stuck into the tip of the introducer needle.The coil wire of the guidewire was stretched out and could not be used.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure, the guidewire allegedly stuck into the tip of the introducer needle.The coil wire of the guidewire was stretched out and could not be used.There was no reported patient injury.

Manufacturer Narrative

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, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one j-tip guidewire within a guidewire hoop was returned for evaluation.Gross visual and dimensional evaluations were performed.The investigation is confirmed for the reported stretched and identified fracture and material protrusion issue as uncoiling was noted o the distal end of the guidewire along with complete circumferential break of the round inner core wire which was protruding from the outer coil is noted.However the investigation is inconclusive for the reported failure to advance and difficult to remove issues, as the exact circumstances at the time of the reported event are unknown and the reported event could not be reproduced in the lab.The measurements of the outer diameter of the guidewire recorded during sample evaluation were slightly below specification but not considered definitely out of tolerance as manufactured as the procedure/use factors could have contributed to a tiny decrease in outer diameter of the guidewire.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.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.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12511148
• MDR Text Key: 272647375
• Report Number: 3006260740-2021-03913
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098246
• UDI-Public: (01)00801741098246
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7707540J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1