C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 7707540J |
Device Problems
Fracture (1260); Stretched (1601); Unraveled Material (1664); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a port placement procedure, the guidewire could not be advanced.It was further reported that when the guidewire was withdrawn outside the patient¿s body, the guidewire was allegedly stretched.There was no reported patient injury.
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Manufacturer Narrative
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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 (expiry date: 01/2025) 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.
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Event Description
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It was reported that during a port placement procedure, the guidewire could not be advanced.It was further reported that when the guidewire was withdrawn outside the patient¿s body, the guidewire was allegedly stretched.There was no reported patient injury.
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Manufacturer Narrative
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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 j-tip guidewire in two segments was returned for evaluation.Functional, gross visual, and dimensional evaluations were performed.The j-tip guidewire was noted to be uncoiled on the distal end.A complete circumferential break was noted on the distal end reflecting deformation and the core wires were noted to be exposed on the distal end reflecting complete breaks.The core wires were noted to be protruding the proximal end of the guidewire segment.Therefore, the investigation is confirmed for the reported stretched and identified unraveled and fracture issues.However, the investigation is inconclusive for the reported failure to advance issue as the exact circumstance at the time of the event reported was 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 the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.
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