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

Catalog Number 0607540CE

Device Problems Difficult to Insert (1316); Device Slipped (1584); Stretched (1601); Deformation Due to Compressive Stress (2889)

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

Event Date 08/12/2021

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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us, but is similar to the x-port isp implantable port, chronoflex single-lumen, 8f products that are cleared in the us.The pro code and 510k number for the x-port isp implantable port, chronoflex single-lumen, 8f products is identified.(expiry date: 03/2023).

Event Description

It was reported that during a port placement procedure, the device guidewire was allegedly bent in the vein.It was further reported that the tip of the introducer needle was bent and the introducer sheath slipped.The procedure was completed using another device.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, chronoflex single-lumen, 8f products that are cleared in the us.The pro code and 510k number for the x-port isp implantable port, chronoflex single-lumen, 8f products is identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 8fr peel-apart sheath, one vessel dilator, one guidewire, one x-port isp, one cath-lock, one introducer needle protector, one cath-lock, and one vein pick.Gross visual, microscopic and dimensional evaluation were performed on the returned device.The investigation is confirmed for the reported deformation due to compressive stress and the identified stretched issue as multiple kinks were observed throughout the guidewire and the outer coils of the guidewire was noted to be uncoiled and distal end of the dilator was noted bent and appeared to be concave and uneven.Bunching was noted on the distal end of the peel apart sheath and the tip observed to be elliptical and concave in one surface and the other surface of the sheath noted to be flattened with lines.However, the investigation is inconclusive for the reported device slipped and difficult to insert issue as the exact circumstances during the reported event were unknown.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: b5, d4 (expiry date: 03/2023.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.

Event Description

It was reported that during a port placement procedure in right sublavian vein, the device guidewire was allegedly bent in the vein.It was further reported that the tip of the introducer needle was bent and the introducer sheath slipped.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: X-PORT ISP
• 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: 12445300
• MDR Text Key: 270536324
• Report Number: 3006260740-2021-03729
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0607540CE
• Device Lot Number: REEZ1834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG