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

Catalog Number	KCFW-5.0-18/38-90-RB-ANL0-HC
Medical Device Problem Codes	Failure to Advance (2524); Delamination (2904)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation begun, but is not yet complete.(b)(4).Investigation - evaluation: a preliminary review of the complaint history, device history record, documentation, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One flexor ansel guiding sheath and both the 0.038 inch endhole and 0.018 inch endhole dilators were returned.Biomatter was present.A small bulge was present in the sheath tubing.Wavy bends were noted on the shaft of the dilators.The outer diameter of both dilators were measured within specification limits.Resistance was encountered upon testing the sheath for transition with both dilators.The sheath proximal fittings were separated for further examination.The tnrt liner was found to be delaminating at the proximal flared section of the sheath tubing.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows one nonconforming events that could contribute to this failure mode.The affected device was rejected and scrapped.A complaint history search revealed that there was one other reported complaint (difficult insertion of the dilator into the sheath) for this lot number.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 preparation for a laser atherectomy, the flexor ansel guiding sheath dilator would not advance through the valve.According to the initial reporter, the device did not come into contact with the patient.Another flexor ansel guiding sheath was opened and utilized to successfully complete the procedure.The patient did not experience any adverse effects due to this occurrence.On 22dec2017 during investigation of the complaint device, it was observed that the tnrt liner was delaminating at the proximal flared section of the sheath tubing.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a small bulge in the sheath tubing approximately 10.0 cm from the proximal hub.Wavy bends in the material were also noted on the shaft of the dilators.After testing the transition with both dilators and the 0.0730" sheath checker and encountering resistance, the sheath proximal fittings were separated for further examination.The liner of the flexor sheath was found to be delaminating at the proximal flared section of tubing.Additionally, a document based investigation evaluation was performed.A review of the device history record showed one nonconforming event which could contribute to this failure mode; however, the nonconforming device was scrapped and not replaced.It should be noted there was one other reported complaint 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.The appropriate personnel have been notified and 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
During a review of the case it was determined that a correction was needed for the aware date of the delamination of the device.B5: on 22jan2018, during investigation of the complaint device, it was observed that the tnrt liner was delaminating at the proximal flared section of the sheath tubing.G4: 01/22/2018.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 ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7213765
• Report Number: 1820334-2018-00287
• Device Sequence Number: 13644140
• Product Code: DYB
• UDI-Device Identifier: 00827002481893
• UDI-Public: (01)00827002481893(17)200807(10)8121068
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/25/2018

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 Catalogue Number: KCFW-5.0-18/38-90-RB-ANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 03/11/2018; 01/22/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 04/03/2018; 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1