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| Catalog Number KCFW-6.0-35-70-RB-HFANL1-HC |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) number = pre-amendment.(b)(4).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, during a pulmonary artery dilatation in (b)(6) 2018, the female patient developed sinus tachycardia, diffuse erythema (thought to be a vasomotor reaction), and felt unwell (malaise and anxiety) upon insertion of a flexor high-flex ansel guiding sheath (please reference medwatch 1820334-2018-02030).Additionally, according to the initial reporter, the patient experienced similar reactions when the flexor high-flex ansel guiding sheath was used at another facility (this report).Information provided stated seven pulmonary angioplasties were performed between (b)(6) 2016 and (b)(6) 2017 followed by two angioplasties in (b)(6) 2018.The reactions occurred during the third procedure.No further information is available regarding this allegation.During follow up with the complainant, it was reported the patient has a history of asthma with atopic tendencies, allergies to vancomycin (expressed as facial edema and skin reaction) not tested by an allergist, and elastoplast (expressed as skin reactions), pulmonary embolism in 2014 (thrombophilia negative record), post embolic portal hypertension - diagnosed in 2016, volibris/adempas introduction in (b)(6) 2016; volibris stopped due to liver toxicity medical records were not provided; however, relevant medications were provided as follows: warfarin rotation between 10 and 11 mg every second day, symbicort turbuhaler 400/12 ug, 1 dose morning and evening, bricanyl turbuhaler 500 mcg/dose , 2 doses if necessary, xyzall 5 mg 1 tablet evening only if rhinitis, adempas 2,5 mg , 1 tablet morning midday evening).Reportedly, a dilatation was performed on (b)(6) 2018 with different equipment and there was no reaction.Exact dates of occurrences, treatment, product and lot numbers were not provided.This information has been requested but has not been received at this time.Per the initial reporter, the complaint device(s) will not be returned to the manufacturer for investigation.
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Manufacturer Narrative
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Upon further review of the complaint it was determined that the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no reported product malfunction.Furthermore, there has been no report that the symptoms experienced by the patient required any medical or surgical intervention.The user facility where the alleged event occurred "was not aware" of this occurrence.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H1: this event does not meet the criteria for a malfunction, serious injury, or death.This report includes information known at this time.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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Upon further review of the complaint it was determined that the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no reported product malfunction.Furthermore, there has been no report that the symptoms experienced by the patient required any medical or surgical intervention.The user facility where the alleged event occurred "was not aware" of this occurrence.
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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.Refer to section h10 for investigation findings.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.A review of the drawing, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.No issues were found related to the reported complaint.The complaint device was not returned; therefore, no physical examinations were able to be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.Because the complaint device was not returned for investigation, no device failure analysis could be performed; however, previously completed biocompatibility testing as well as clinical device history showed that all materials used in this device have been proven to be biocompatible.Based on the information provided and the results of our investigation, a definitive root cause could not be determined however, measures have been previously initiated to address this issue.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed 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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Previously submitted on 03oct2019: upon further review of the complaint, it was determined that the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no reported product malfunction.Furthermore, there has been no report that the symptoms experienced by the patient required any medical or surgical intervention.The user facility where the alleged event occurred "was not aware" of this occurrence.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction: this report is being submitted retrospectively per fda request.The information in this report was previously submitted on 10sep2018 on a report with an incorrect follow up # 2 and on 03oct2019 on a report with an incorrect follow up #3.Therefore, this report is being submitted as a correction follow up # 1 with the information from both of the previously submitted follow ups.Previously submitted on 10sep2018: a review of the drawing, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.No issues were found related to the reported complaint.The complaint device was not returned; therefore, no physical examinations were able to be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.Because the complaint device was not returned for investigation, no device failure analysis could be performed; however, previously completed biocompatibility testing as well as clinical device history showed that all materials used in this device have been proven to be biocompatible.Based on the information provided and the results of our investigation, a definitive root cause could not be determined however, measures have been previously initiated to address this issue.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.Previously submitted on 03oct2019: upon further review of the complaint it was determined that the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no reported product malfunction.Furthermore, there has been no report that the symptoms experienced by the patient required any medical or surgical intervention.The user facility where the alleged event occurred "was not aware" of this occurrence.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H1: this event does not meet the criteria for a malfunction, serious injury, or death.This report includes information known at this time.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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Search Alerts/Recalls
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