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

Model Number	G56230
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: pre-amendment.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 peripheral procedure involving a patient of unknown age and gender, a flexor high-flex ansel guiding sheath separated upon removal of the device.The patient reportedly had severely calcified vessels, including a severely calcified aortic bifurcation.The device was advanced over the aortic bifurcation using an unknown amplatz wire; however, the device was not able to be advanced all the way so the decision was made to remove the device.The user reinserted the wire guide but was unable to advance it.The user pulled the sheath back and it separated outside of the body, leaving a portion in the patient still attached to the inner coil.The physician was able to remove the entire device from the patient.Another device of the same type, along with a lunderquist wire, was used to complete the procedure.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 information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
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
Investigation/evaluation: reviews of the manufacturing instructions, complaint history, device history record, documentation, instructions for use (ifu), and quality control procedures, as well as a dimensional verification and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed separation of the device.All separation sites were stretched and frayed, and the tubing pieces were connected with coiling.The proximal separated tubing segment included the check-flo body and measured 33.4cm with 2.5cm of coiling exiting the separation site.This coiling connected to segment 2, which measured 1cm long with 2.3cm of exposed coiling exiting the separation site.This coiling connected to segment 3, which measured 1.9cm with one coil exiting the separation site.This coil connected to segment 4, which measured 5mm with one coil exiting the separation site.This coil connected to segment 5, which measured 6mm with 8.2cm of coiling exiting the separation site.This coiling connected to segment 6, which measures 17.9cm.There were sections of inner tnrt lining attached to several of the coiling sections.The coiling inside of all sections was elongated.The distal tip was intact, and the marker band was present.Biomatter was found throughout the device.No hemostat marks or kinks were observed, and the dilator was not returned.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.It should be noted there were no other reported complaints for this lot number.The instructions for use provided with the device state under the section 'sheath removal,' "if resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit." the user reportedly did not reinsert the dilator prior to sheath removal.Furthermore, reviews of the manufacturer¿s instructions 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 the device failure can be attributed to the patient¿s reportedly severely calcified anatomy, and to the user¿s failure to insert the dilator prior to sheath removal.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.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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 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: 8757863
• Report Number: 1820334-2019-01602
• Device Sequence Number: 2296249
• Product Code: DYB
• UDI-Device Identifier: 00827002562301
• UDI-Public: (01)00827002562301(17)220328(10)9625809
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• Initial Reporter Occupation: Physician
• 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: 03/28/2022
• Device Model Number: G56230
• Device Catalogue Number: KCFW-5.0-35-55-RB-HFANL0-HC
• Device Lot Number: 9625809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 03/20/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 09/06/2019; 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1