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

Catalog Number	KCFW-6.0-35-55-RB-HFANL1-HC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an angiography procedure, the tip of a flexor high-flex ansel guiding sheath separated.Access was obtained in the femoral artery.Another manufacturer's wire guide was placed, followed by an unspecified pigtail angiography catheter, which was placed to cross the iliac artery.Once the angiography catheter was advanced over the iliac artery, the complaint device was placed to establish a more effective "support access".Significant resistance was not encountered upon insertion of the sheath.During the angiogram, the tip of the sheath was not seen.The sheath was immediately removed from the patient, without encountering significant resistance.Angiography was performed on the affected limb, starting from the knee to the tibiofibular trunk, popliteal artery, femoral artery, and iliac artery to the puncture point.No foreign body was observed.The user assumed that the tip separated prior to insertion into the patient.Another device of the same type was used to complete the procedure successfully.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 Manufacturer Narrative
E1: customer name and address= address: (b)(6).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 an angiography procedure, the tip of a flexor high-flex ansel guiding sheath separated.Access was obtained in the femoral artery.Another manufacturer's wire guide was placed, followed by an unspecified pigtail angiography catheter, which was placed to cross the iliac artery.Once the angiography catheter was advanced over the iliac artery, the complaint device was placed to establish a more effective "support access".Significant resistance was not encountered upon insertion of the sheath.During the angiogram, the tip of the sheath was not seen.The sheath was immediately removed from the patient, without encountering significant resistance.Angiography was performed on the affected limb, starting from the knee to the tibiofibular trunk, popliteal artery, femoral artery, and iliac artery to the puncture point.No foreign body was observed.The user assumed that the tip separated prior to insertion into the patient.Another device of the same type was used to complete the procedure successfully.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), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of photos provided by the customer was also conducted.The complaint device was not returned to cook for investigation; however, photos were provided by the customer, showing that the sheath tip was broken or had separated.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and examination of photos 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.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 has concluded that a component failure, unrelated to manufacturing or design, contributed to this event.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: 17405918
• Report Number: 1820334-2023-00968
• Device Sequence Number: 20672019
• Product Code: DYB
• UDI-Device Identifier: 00827002562363
• UDI-Public: (01)00827002562363(17)240713(10)14084424
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 07/13/2024
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL1-HC
• Device Lot Number: 14084424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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: TERUMO 2.6 METER SOFT WIRE GUIDE
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 70 KG