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

Catalog Number	KSAW-6.0-18/38-55-RB-ANL1-HC
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary of event: as reported, upon completion of an angiogram of the left leg, a flexor ansel guiding sheath "sheered".Access was obtained in the right groin to target the left superficial femoral artery (sfa).The bifurcation was "pretty acute" and calcified, however, there was no resistance advancing the sheath or any device, including another manufacturer's balloons, through the sheath.Upon removal of the sheath after the procedure had been successfully completed, resistance was felt, and the dilator was inserted.Resistance was still felt; however, the sheath was successfully removed, and "sheering" was noted approximately midway down the sheath.Per the reporter, the sheath looked like it had been "traveled over rough terrain and was very ratty".There was no separation of the sheath.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, a hole was noted in the sheath exposing the inner coil.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection and dimensional verification were conducted as well.The complaint device was returned to cook for investigation.A hole on the sheath exposing the inner coil and a tip that was slightly out of round.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu was reviewed and states ¿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.¿ 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, returned device, and complaint file suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy likely contributed to this event.The user experienced difficulty during removal of the sheath.It was reported the bifurcation was acute, and the physician felt there was calcification right at the bifurcation, thus possibly causing the device to be difficult to remove.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Event or Problem Description
As reported, upon completion of an angiogram of the left leg, a flexor ansel guiding sheath "sheered".Access was obtained in the right groin to target the left superficial femoral artery (sfa).The bifurcation was "pretty acute" and calcified, however, there was no resistance advancing the sheath or any device, including another manufacturer's balloons, through the sheath.Upon removal of the sheath after the procedure had been successfully completed, resistance was felt and the dilator was inserted.Resistance was still felt, however, the sheath was successfully removed and "sheering" was noted approximately midway down the sheath.Per the reporter, the sheath looked like it had been "traveled over rough terrain and was very ratty".There was no separation of the sheath.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, a hole was noted in the sheath exposing the inner coil.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.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.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18906518
• Report Number: 1820334-2024-00348
• Device Sequence Number: 15737219
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)260511(10)15434530
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2026
• Device Catalogue Number: KSAW-6.0-18/38-55-RB-ANL1-HC
• Device Lot Number: 15434530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MUSTANG BALLOONS
• Patient Sex: Unknown