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 Degraded (1153); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Patient Device Interaction Problem (4001)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that thirteen years and five months post port placement.When the port system was attempted to be removed, it was allegedly difficult to remove the catheter.It was further reported that when the removed catheter was checked, the surface of the catheter was uneven and rough.Reportedly, there was no breakage of the catheter and no remains in the patient's body.Furthermore, the port and the catheter was removed.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: 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.H10: d4 (expiration date: 07/2012).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.

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: 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 x-port implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic, tactile and functional testing were performed.During microscopic evaluation, degradation was noted throughout the catheter and the catheter was noted to be rough to the touch.Therefore, the investigation is confirmed for the identified degraded issue.However, the investigation is inconclusive for the reported difficult to remove and deformation issue, as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2012).H11: section a through f ¿ the information provided by bd represents all 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 thirteen years and five months post port placement, when the port system was attempted to be removed, it was allegedly difficult to remove the catheter.It was further reported that when the removed catheter was checked, the surface of the catheter was uneven and rough.Reportedly, there was no breakage of the catheter and no remains in the patient's body.Furthermore, the port and the catheter was removed.There was no reported patient injury.

Event Description

It was reported that thirteen years and five months post port placement, when the port system was attempted to be removed, it was allegedly difficult to remove the catheter.It was further reported that when the removed catheter was checked, the surface of the catheter was uneven and rough.Reportedly, there was no breakage of the catheter and no remains in the patient's body.Furthermore, the port and the catheter was removed.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: 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 x-port implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic, tactile and functional testing were performed.During microscopic evaluation, tissue adhesion was noted throughout the catheter and the catheter was noted to be rough to the touch.Therefore, the investigation is confirmed for the identified deformation and patient device interaction issue.However, the investigation is inconclusive for difficult to remove as the conditions of use (device implanted for over 13 years) could not be recreated.It was reported that the device was implanted for more than thirteen years.Therefore, it is possible that the length of the implant contributed to the removal difficulties and the tissue adhesion along the length of the catheter.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2012), g3.H11: h6 (device, result).H11: section a through f ¿ the information provided by bd represents all 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17404034
• MDR Text Key: 320588961
• Report Number: 3006260740-2023-03212
• 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,Followup
• Report Date: 01/04/2024

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 Catalogue Number: 7707540J
• Device Lot Number: RETI1081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 12/13/2023; 01/04/2024
• Supplement Dates FDA Received: 12/13/2023; 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2009
• 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 Sex: Female