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

Model Number	G56233
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, upon opening the device and prior to contact with a (b)(6) year-old male patient with a history of lower extremity arterial occlusion, a flexor high-flex ansel guiding sheath was "broken" at the proximal end of the device.Photos provided by the initial reporter show separation of sheath material.The intended procedure was stent placement within the iliac artery.Another device was used to complete the procedure.The complaint device did not make contact with the patient.There has been no report that the patient experienced any adverse effects resulting from this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection of the returned device as well as an inspection of an unused product were conducted during the investigation.The visual inspection of the returned package confirmed that one flexor high-flex ansel guiding sheath and a dilator were returned to cook for investigation.The dilator was returned without damage.A small amount of bio-matter was noted on the check-flo cap and the sheath end hole.A separation was noted in the sheath material 2mm from the check-flo but was still connected by the inner coiling.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.However, while reviewing the subassembly lot, there were leak tests nonconformances noted.While these were potentially related to the reported failure, it should be noted that the effected units were scrapped prior to final assembly.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this failure could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8896718
• Report Number: 1820334-2019-02019
• Device Sequence Number: 285445
• Product Code: DYB
• UDI-Device Identifier: 00827002562332
• UDI-Public: (01)00827002562332(17)220402(10)9636261
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2020

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: 04/02/2022
• Device Model Number: G56233
• Device Catalogue Number: KCFW-8.0-35-55-RB-HFANL0-HC
• Device Lot Number: 9636261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/19/2019; 03/18/2020
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/20/2019; 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR