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

Model Number	G44153
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfg.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.
Event or Problem Description
As reported, during an aortogram of the right extremity, via left-sided access, a flexor ansel guiding sheath separated in the patient upon removal of the device.The vessels were reportedly extremely calcified, and resistance was encountered upon removal of the sheath.The separated portion of the device was removed from the patient with a cloversnare.The procedure was completed at the time of the separation.Upon return and initial evaluation of the device, it was noted that the sheath had also unraveled and delaminated at the point of separation.A section of the device did not remain inside the patient¿s 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.Additional information has been requested.
Event or Problem Description
Additional information was received 01jun2022.Access was obtained in the femoral artery.The dilator was in place at the time of separation; however, no other devices were in the lumen of the sheath at the time of separation.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Summary of event: as reported, during an aortogram of the right extremity, via left-sided access, a flexor ansel guiding sheath separated in the patient upon removal of the device.Access was obtained in the femoral artery.The vessels were reportedly extremely calcified, and resistance was encountered upon removal of the sheath.The separated portion of the device was removed from the patient with a cloversnare.The procedure was completed at the time of the separation.The dilator was in place at the time of separation; however, no other devices were in the lumen of the sheath at the time of separation.Upon return and initial evaluation of the device, it was noted that the sheath had also unraveled and delaminated at the point of separation.A section of the device did not remain inside the patient¿s 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.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook.The sheath was received in two pieces, with elongation and twisting of the material noted opposite of the distal end.Coils exited the section of the sheath with the hub, and the clear membrane was exposed.The second section included a kinked and smashed distal tip.A document-based investigation evaluation was performed.One relevant non-conformance was noted on a subassembly lot.One additional complaint was found on a subassembly lot; however, the complaint involved an unrelated failure mode.There were no additional complaints on the complaint device finished lot.Although one relevant non-conformance was noted, all affected product was scrapped, 100% inspections are in place, and no other relevant complaints have been received from the field.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device 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.The product ifu warns, ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ the ifu also cautions, ¿in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook is unable to establish a cause for this event.It is possible that using a sheath that was undersized for the laser and the patient¿s anatomy contributed to the incident, but this cannot be confirmed.A capa remains open to further investigate this failure mode.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 has been received since the last report was submitted.

• 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: 14495793
• Report Number: 1820334-2022-00970
• Device Sequence Number: 6150862
• Product Code: DYB
• UDI-Device Identifier: 00827002441538
• UDI-Public: (01)00827002441538(17)240223(10)13776463
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2024
• Device Model Number: G44153
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 13776463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 07/21/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/06/2022; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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: ABBOTT .014 BALLOON.; ABBOTT .018 ANGIOPLASTY BALLOON.; PHILIPS LASER.; ROADRUNNER .014 WIRES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown