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

Model Number	G56231
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a left leg angiogram procedure with intervention, the flexor high-flex ansel guiding sheath was difficult to remove as it was not "backing-out" over the wire.Access was gained via the right groin targeting the patient¿s perineal artery.The patient did not have tortuous, calcified, or scarred anatomy.Upon removal of the sheath, resistance was felt.The physician attempted to put the dilator through the sheath, but it would not go through; however, it did allow the sheath to ¿loosen-up¿ and come across the bifurcation to be removed.A part of the sheath was flattened upon removal from the patient.The procedure was successfully completed with the device in question.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 Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation = lead tech.H3: device evaluated by manufacturer = device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a left leg angiogram procedure with intervention, the flexor high-flex ansel guiding sheath was difficult to remove as it was not "backing-out" over the wire.Access was gained via the right groin targeting the patient¿s perineal artery.The patient did not have tortuous, calcified, or scarred anatomy.Upon removal of the sheath, resistance was felt.The physician attempted to put the dilator through the sheath, but it would not go through; however, it did allow the sheath to ¿loosen-up¿ and come across the bifurcation to be removed.A part of the sheath was flattened upon removal from the patient.The procedure was successfully completed with the device in question.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.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.The sheath was flattened/compressed twenty-five centimeters from the hub and extending approximately one centimeter from the distal tip.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the complaint lot or subassembly lots.A review of complaint history found no additional complaints for this lot number.The product ifu 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 component failure contributed to this incident.The user experienced trouble during removal of the sheath and tried to reinsert the dilator, but the sheath would not allow the dilator to insert.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.

• Brand Name: FLEXOR HIGH-FLEX 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: 19766921
• Report Number: 1820334-2024-00969
• Device Sequence Number: 12906235
• Product Code: DYB
• UDI-Device Identifier: 00827002562318
• UDI-Public: (01)00827002562318(17)270430(10)16034029
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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 Model Number: G56231
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL0-HC
• Device Lot Number: 16034029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: 035 ZIP WIRE; COOK ADVANCE 18LP 6MM X 10CM ANGIOPLASTY BALLOON; COOK ROADRUNNER EXTRA SUPPORT WIRE; MERIT RIM CATHETER; SPECTRANETICS LASER CATHETER
• Patient Sex: Female