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

Model Number	G48186
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address: line 2 address: (b)(6).Postal code: (b)(6).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.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
As initially reported, the dilator could not be inserted into the hemostatic valve of a flexor ansel guiding sheath.When the user pushed the dilator with force, it kinked.The device was replaced with another manufacturer's long sheath and the procedure was completed successfully.There were no adverse effects to the patient.Upon evaluation of the device on (b)(6) 2022, it was noted that the sheath was delaminating.
Event or Problem Description
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Summary of event: as initially reported, the dilator could not be inserted into the hemostatic valve of a flexor ansel guiding sheath.When the user pushed the dilator with force, it kinked.The device was replaced with another manufacturer's long sheath and the procedure was completed successfully.There were no adverse effects to the patient.Upon evaluation of the device on 16jun2022, it was noted that the sheath was delaminating.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 and dimensional verification of the complaint device was also conducted.The complaint device was returned to cook for investigation with two dilators.After disassembling the hub, the inner lining of the sheath was noted to be delaminating, causing the sheath to be blocked.The 0.018-inch dilator was kinked, and the 0.035-inch dilator was damaged.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 investigation of the returned device suggests that there is evidence the device was manufactured out of specification; however, there is no evidence of additional non-conforming devices in-house or in the field, as there were no related non-conformances or additional complaints on the lot.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 manufacturing and quality control deficiency 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 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: 14758881
• Report Number: 1820334-2022-01098
• Device Sequence Number: 11096458
• Product Code: DYB
• UDI-Device Identifier: 00827002481862
• UDI-Public: (01)00827002481862(17)230818(10)13375214
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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: 08/18/2023
• Device Model Number: G48186
• Device Catalogue Number: KCFW-4.0-18/35-45-RB-ANL0-HC
• Device Lot Number: 13375214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2020
• 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 LONG SHEATH
• Patient Sex: Unknown