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Catalog Number 085110 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Pseudoaneurysm (2605)
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Event Date 04/05/2012 |
Event Type
Injury
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Manufacturer Narrative
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Literature article/journal; apr2012: gnessin, e., mandeville, j.A., handa, s.E., et.Al., 2012, the utility of noncontrast computed tomography in the prompt diagnosis of postoperative complications after percutaneous nephrolithotomy.Pma/510(k) number = k191498.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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It was reported that a total of 51 patients underwent a pnl procedure.A total of 48 patients developed a perinephric hematoma post-op; two patients required embolization, 9 patients required blood transfusions, and 32 patients required an unspecified conservative [non-surgical] treatment.A total of 3 patients developed a pseudoaneurysm post-op; 2 of those patients required embolization.A section of the device did not remain inside the patient¿s body.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: b3 event description: it was reported that a total of 51 patients underwent a pnl procedure.A total of 48 patients developed a perinephric hematoma post-op; two patients required embolization, 9 patients required blood transfusions, and 32 patients required an unspecified conservative [non-surgical] treatment.A total of 3 patients developed a pseudoaneurysm post-op; 2 of those patients required embolization.A section of the device did not remain inside the patient¿s body.Investigation - evaluation reviews of instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The current quality control procedures were inspected instead of the controls at the time of the journal article for the sake of relevance.It was concluded that sufficient inspection activities are in place to identify device functionality prior to distribution.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) that is currently packaged with the device was reviewed for relevant information pertaining to the reported failure mode.Contraindications: this device should not be used in the presence of coagulopathy.Catheter placement: ¿introduce the 21-gauge needle below the twelfth rib, about five finger-breadths from the midline.Advance the needle in short steps toward the lower pole until the needle is seen moving with respiration.While the patient holds his or her breath, advance the needle no further than 3cm.If urine is not aspirated, repeat the process using a slightly different angle until a calyx is successfully punctured.¿ there is a limited availability of information given the date the study was published.Potential causes for the failure mode are patient factors, inadvertent user issues, and procedural issues.The current instructions for use that is packaged with the device was inspected and determined to contain adequate instructions for the application of the device and how to prevent misplacement/malposition of the device and the potential harms that could result from such an occurrence.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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