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

Model Number	G56232
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.Investigation: evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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
It was reported, a flexor high-flex ansel guiding sheath completely broke off inside a patient of unspecified gender and age but was successfully retrieved in an unknown manner.The unspecified procedure was successfully completed with a good patient outcome.The patient did not experience any adverse effects as a result of this occurrence.No further information is available.The complaint device will not be returned to the manufacturer to aid in the investigation.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.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.
Event or Problem Description
No new patient or event information received since the last report was submitted.

• 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: 8413692
• Report Number: 1820334-2019-00547
• Device Sequence Number: 18910442
• Product Code: DYB
• UDI-Device Identifier: 00827002562325
• UDI-Public: (01)00827002562325(17)211119(10)9321436
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 11/19/2021
• Device Model Number: G56232
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL0-HC
• Device Lot Number: 9321436
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 03/19/2020
• 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: Required Intervention