COOK INC TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER; KGZ ACCESSORIES, CATHETER
|
Back to Search Results |
|
Catalog Number PTBYC-RA |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown or unavailable.E1 - name and address: (b)(6).G4 - pma/510(k)# = exempt.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.
|
|
Event Description
|
As reported, during an arteriogram with intervention procedure, the user had hard time tightening a tuohy-borst large bore clear plastic sidearm adapter so it will not leak.There have been no adverse effects reported due to this occurrence.Additional information has been requested.
|
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.
|
|
Event Description
|
Additional information was received 05jan2024.An unspecified 0.035-inch wire guide was used during the procedure.No other devices were placed through the adapter, as the tuohy would not tighten.Another tuohy device was used to successfully complete the procedure.The patient did not require treatment for blood loss, as blood loss did not occur.The patient did not require any additional interventions or procedures due to this event.
|
|
Event Description
|
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
|
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an arteriogram with intervention procedure, the user had hard time tightening a tuohy-borst large bore clear plastic sidearm adapter so it will not leak.There have been no adverse effects reported due to this occurrence.Additional information was received (b)(6) 2024.An unspecified 0.035-inch wire guide was used during the procedure.No other devices were placed through the adapter, as the tuohy would not tighten.Another tuohy device was used to successfully complete the procedure.The patient did not require treatment for blood loss, as blood loss did not occur.The patient did not require any additional interventions or procedures due to this event.Investigation evaluation: reviews of the complaint history, device history record, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record found one relevant non-conformance on 3 devices; however, all affected product was scrapped.A review of complaint history found no additional complaints for this lot number.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 and dhr suggests that there is evidence the device was manufactured to specification.Although one relevant non-conformance was noted on the complaint 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 component failure, unrelated to manufacturing or design deficiencies, contributed to this incident.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.
|
|
Search Alerts/Recalls
|
|
|