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

Model Number	G13539
Medical Device Problem Codes	Material Separation (1562); Uncoiled (1659)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that during a carotid stenting procedure, the flexor shuttle tibial guiding sheath was removed over a wire without a dilator and became completely uncoiled.The sheath separated in half with the coiling exposed.The distal portion of the sheath remained within the abdominal aorta and iliac, and was required to be surgically removed.It was noted that the patient's vessels were likely calcified.Access was gained from the patient's groin; a wire guide was utilized through the sheath during the event.The following devices (unspecified manufacturer) were also inserted into the lumen of the sheath prior to removal: stents, balloon, and possibly a carotid filter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the sheath tubing was separated into 3 segments.Altogether, the measured length of the returned tubing was 54.5 cm.The most distal portion of the device was not returned.The first segment (proximal) measured 39.5 cm in length, and the second segment measured 15.0 cm in length.Exposed coil was exiting the second segment.Pieces of separated sheath liner were found to be embedded within the exposed coil.The proximal tubing segment contained multiple kinks/flattened portions of tubing, and appeared to be stretched.The second tubing segment also had flattened portions of tubing, and appeared to be stretched.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.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Additional Manufacturer Narrative
Device evaluation begun, but is not yet complete.Additional information per voluntary sus report mw5075332 received 12mar2018: initial report also sent to fda?: reported to fda.Per sus report mw5075332, "patient underwent a carotid artery angioplasty in 2018 in emergency room (er).As sheath was being removed from groin it detached from itself and attempts to remove it were unsuccessful.Vascular surgery consulted and patient went to operating room for removal of sheath." 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.(b)(4).
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
Correction: d1, d4, g5, h4.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.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7282749
• Report Number: 1820334-2018-00535
• Device Sequence Number: 18865772
• Product Code: DYB
• UDI-Device Identifier: 00827002135390
• UDI-Public: (01)00827002135390(17)200109(10)7571368
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142819
• 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,Followup,Followup
• Report Date (Section B): 03/25/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2020
• Device Model Number: G13539
• Device Catalogue Number: KSAW-6.0-38-80-RB-SHTL-HC
• Device Lot Number: 7571368
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/12/2018; 03/23/2018; 03/24/2020
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/19/2018; 04/17/2018; 03/25/2020
• 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