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

Model Number	G56221
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer name and address= phone: (b)(6).(b)(4).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 unknown procedure, a flexor high-flex ansel guiding sheath separated in the patient upon removal of the device.The separated portion of the device was retrieved via a surgical procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested, but is unavailable at this time.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Event summary: as reported, during an unknown procedure, a flexor high-flex ansel guiding sheath separated in the patient upon removal of the device.The separated portion of the device was retrieved via a surgical procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, documentation, drawing, specifications, manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.A search of cook¿s inventory determined that all devices from the complaint lot were already outside of cook¿s control and thus a representative device from the lot could not be examined.A review of complaint history records shows no other complaints and no non-conformances associated with the complaint device lot.A clinical assessment concluded that: with the limited information available, causes for the event such as patient anatomy, user/procedural issues, manufacturing issues, and/or device failure cannot be ruled out.Capa 171969 was previously initiated regarding this failure mode.The process of assembling the sheath was successfully validated to iso11070 for tensile strength; the minimum load required for failure (separation) was greater than 15 n.The capa team did not arrive at a definitive root cause and was closed at the end of the root cause phase.The following primary contributing factors have been identified: a.) these devices can be advanced into restrictive anatomies.The capa investigation showed that clinical users may be using these devices to force through restrictive anatomy, causing separation upon removal.B.) instructions for use warn to reinsert the dilator prior to removal.Investigation has identified that this is not always performed.While a definitive cause for this failure could not be determined, there was no evidence to suggest manufacturing issues were the cause.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11133732
• Report Number: 1820334-2021-00036
• Device Sequence Number: 689031
• Product Code: DYB
• UDI-Device Identifier: 00827002562219
• UDI-Public: (01)00827002562219(17)220516(10)9744785
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 05/16/2022
• Device Model Number: G56221
• Device Catalogue Number: KCFW-6.0-35-70-RB-HFANL0-HC
• Device Lot Number: 9744785
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention