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

Model Number	G44155
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: amplatz extra stiff 180 cm, amplatz super stiff 180 cm, cxi catheter 0.035 x 90 cm, cto 18 gr x 300 cm wire, roadrunner glide 260 cm, rosen 260 cm, zilver ptx 6 mm x 40 mm, zilver ptx 6 mm x 100 mm, boston jetstream 2.1/3.0 atherectomy catheter, abbott emboshield nav6 7.2 mm filter, barewire 315 cm, tempo 4fx65 cm omniflush catheter (b)(4).Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported during a lower left extremity angiogram in a (b)(6) year old male patient with a history of hypertension, type ii diabetes, peripheral artery disease and neuropathy, the flexor ansel guiding sheath elongated and separated.Access was gained through the right common femoral artery using a retrograde approach and the sheath was in place for approximately three hours.The patient was given fentanyl, midazolam, heparin, nitroglycerin, rotaglide during the procedure.Reportedly, there was extensive scarring in the groin, and the physician noted both a difficult insertion and removal.When attempting to remove the device from the patient with the dilator and a wire guide inserted, the sheath separated.The separation occurred approximately 3 cm from the tip of the shaft.The patient was then transferred for surgical extraction of the retained sheath tip.The segment was successfully removed and the patient is in recovery.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.
Event or Problem Description
Additional information has been received noting that mdr#1820334-2019-01897 and mdr#1820334-2019-01706 are actually the same event.The complaint file associated with 01897 has been closed/cancelled.Moving forward, all additional information, as well as the investigation evaluation will be provided on 01706.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8852003
• Report Number: 1820334-2019-01897
• Device Sequence Number: 259797
• Product Code: DYB
• UDI-Device Identifier: 00827002441552
• UDI-Public: (01)00827002441552(17)220516(10)9744836
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: G44155
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 9744836
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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
• Patient Age: 72 YR
• Patient Weight: 112