BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053
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Model Number D-1336-00 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Hematoma (1884)
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Event Date 03/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number can not be provided.Concomitant medical products: carto 3 system; model #: m-4800-01; serial #: unknown.(b)(4).
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Event Description
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It was reported that a patient underwent an ablation procedure with a thermocool smarttouch uni-directional catheter and suffered a hematoma, pulmonary congestion, and a urinary infection.There is no information about the hospitalization and if any intervention was performed.No information is known regarding the patient status.The physician did not provide a causality opinion for the cause of this adverse event.Since this adverse event might result in permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.
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Manufacturer Narrative
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This is a correction as in the 3500a initial report the following statement was added in error: ¿since the lot number is unknown, the full udi number can not be provided.¿ manufacturer's ref.No: (b)(4).
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Manufacturer Narrative
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Additional information was received on the event on june 8, 2017.The patient also suffered post-procedure dyspnea (requiring no medical or surgical intervention).The dyspnea issue is ongoing.The principal investigator assessed the dyspnea as possibly procedure-related.(b)(4).
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Manufacturer Narrative
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Additional information was received regarding interventions and patient outcomes on september 22, 2017.During the procedure, the patient developed a hematoma.No interventions were performed.Issue resolved without sequelae.Principal investigator assessed this event as mild in severity, not serious, not investigational device-related, and definitely index procedure-related.On post-procedure day 2, the patient developed a urinary tract infection.An unspecified medication was administered.Issue resolved without sequelae.Principal investigator assessed this complaint as moderate in severity, not serious, not investigational device-related, and probably index procedure-related.On post-procedure day 2, the patient developed pulmonary edema.An unspecified medication was administered.Issue resolved without sequelae.Principal investigator assessed this event as moderate in severity, not serious, not investigational device-related, and probably index procedure-related.On post-procedure day 1, the patient developed dyspnea.No interventions were administered.Issue resolved without sequelae.Principal investigator assessed this event as mild in severity, not serious, not investigational device-related, and possibly index procedure-related.(b)(4).
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Manufacturer Narrative
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Originally, the product reported was a thermocool smarttouch uni-directional catheter / model #: d-1336-00 / lot #: unknown_d-1336-00.Additional information was received on september 4, 2017 providing a corrected product.The correct product is thermocool smarttouch bidirectional navigation catheter / model #: d-1327-05-s/lot #: unk_d-1327-05-s.Since the lot number is unknown, the full udi number can not be provided.(b)(4).
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Manufacturer Narrative
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Additional information was provided on march 11, 2019 stating that the patient was a 66 year old female.Legacy manufacturer¿s reference number: (b)(4).Manufacturer¿s reference number: (b)(4).
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Search Alerts/Recalls
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