BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Model Number D128208 |
Device Problems
Entrapment of Device (1212); Failure to Unfold or Unwrap (1669)
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Patient Problem
No Code Available (3191)
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Event Date 06/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that during an idiopathic ventricular tachycardia (idvt) ablation procedure, a pentaray nav high-density mapping eco catheter was used to map the left ventricle.At that time, the physician started to have difficulty in maneuvering the catheter.The catheter shaft became entrapped in the vessel and could not be taken out of there or into the sheath.The deflection was relaxed and it still did not allow the catheter to be withdrawn.An interventional cardiologist was called.The catheter became unknotted and could be successfully removed from the patient¿s body.No patient consequences were reported.The procedure was delayed by 30 minutes.In physician¿s opinion, the delay did not pose a risk to the patient.No device components became detached.The issue did not result in exposure of any internal catheter components or sharp edges.Catheter could still be deflected and pushed up or down with limits.Since surgical intervention was required to prevent permanent impairment of a body function or permanent damage to a body structure, then this event was assessed as serious and mdr reportable.The described medical device entrapment with excessive manipulation required and the knotted catheter issues were also assessed as mdr reportable issues.
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Manufacturer Narrative
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It was reported that during an idiopathic ventricular tachycardia (idvt) ablation procedure, a pentaray nav high-density mapping eco catheter was used to map the left ventricle.At that time, the physician started to have difficulty in maneuvering the catheter.The catheter shaft became entrapped in the vessel and could not be taken out of there or into the sheath.The deflection was relaxed and it still did not allow the catheter to be withdrawn.An interventional cardiologist was called.The catheter became unknotted and could be successfully removed from the patient¿s body.No patient consequences were reported.The procedure was delayed by 30 minutes.In physician¿s opinion, the delay did not pose a risk to the patient.No device components became detached.The issue did not result in exposure of any internal catheter components or sharp edges.Catheter could still be deflected and pushed up or down with limits.The biosense webster inc.(bwi) product analysis lab (pal) received a picture for analysis.The photograph investigation was completed on (b)(6)2020.According to the picture provided by the customer, a knotted catheter was observed on the screen.A manufacturing record evaluation was performed for the finished, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed; however, the device has not been returned for analysis.Therefore, it is not possible to determine the root cause of the failure.If the device is received in the future, the product investigation will be performed as appropriate in order to find the potential root cause of the complaint.Additional information was received on july 6, 2020 providing an update that the hospital was keeping the catheter.Therefore, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000708149.
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