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E3: occupation = radiologic technician.G4: pma/510(k) number = k170193.H3: device evaluated by manufacturer = device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device valuation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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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As reported, during an unspecified procedure, an advance 14 lp low profile balloon catheter ruptured upon initial inflation in the perineal artery with an unspecified inflation device.Access was obtained in the right femoral artery over another manufacturer's wire, and the anatomy was mildly calcified.A section of the device did not remain inside the patient.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unspecified procedure, an advance 14 lp low profile balloon catheter ruptured upon initial inflation in the perineal artery with an unspecified inflation device.Access was obtained in the right femoral artery over another manufacturer's wire, and the anatomy was mildly calcified.A section of the device did not remain inside the patient.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information received 16jul2024 stating the "vessel was successfully treated utilizing a second balloon".Corrected information: d4, h6 (annex a).Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.A pinhole leak was noted near the proximal bond of the balloon, confirmed with leak testing.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final lot.Two relevant non-conformances were noted on a sub-assembly lot on five total devices; however, all affected product was scrapped prior to release.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿if balloon pressure is lost and/ or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Although two relevant non-conformances were noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.It is possible that the patient¿s calcified anatomy contributed to this event; however, this could not be definitively confirmed.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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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