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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

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COOK INC FLEXOR ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER Back to Search Results
Model Number G29982
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
 
Event Description
As reported, during an unspecified renal procedure, the hub of a flexor ansel guiding sheath separated from the device upon removal from the patient.Removal was difficult and resistance was reported.The patient had fibrotic tissue at the superficial femoral artery access site and proximal right iliac from a previous open femoral bypass surgery.An unknown renal stent and guidewires were used during the procedure, and heparin was given.The sheath was inserted to 45-centimeters.The dilator was not in place upon removal of the device or at the time of separation.Blood loss was reported; however, no intervention was required to treat blood loss.The device was successfully removed from the patient, who is reportedly "ok".A section of the device did not remain inside the patients body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Event Description
No new patient or event information to report.
 
Manufacturer Narrative
Description of event: as reported, during an unspecified renal procedure, the hub of a flexor ansel guiding sheath separated from the device upon removal from the patient.Removal was difficult and resistance was reported.The patient had fibrotic tissue at the superficial femoral artery access site and proximal right iliac from a previous open femoral bypass surgery.An unknown renal stent and guidewires were used during the procedure, and heparin was given.The sheath was inserted to 45-centimeters.The dilator was not in place upon removal of the device or at the time of separation.Blood loss was reported; however, no intervention was required to treat blood loss.The device was successfully removed from the patient, who is reportedly "ok".Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.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 made out of specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.¿ precautions: ¿while inserting, manipulating or withdrawing a device through the sheath, always maintain sheath position.¿ instructions for use: ¿sheath removal: insert a wire guide until its tip extends at least 10cm past the tip of the sheath.Remove the sheath.Avoid applying traction to hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.Remove the wire guide." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded the patient condition possibly contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
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Brand Name
FLEXOR ANSEL GUIDING SHEATH
Type of Device
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key11359583
MDR Text Key243980981
Report Number1820334-2021-00370
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002299825
UDI-Public(01)00827002299825(17)230812(10)13363201
Combination Product (y/n)N
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/12/2023
Device Model NumberG29982
Device Catalogue NumberKCFW-6.0-18/38-45-RB-ANL1-HC
Device Lot Number13363201
Was Device Available for Evaluation? No
Date Manufacturer Received04/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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