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

Catalog Number	KCFW-5.0-35-55-RB-HFANL0-HC
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Wrinkled (2614)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
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, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One flexor high-flex ansel guiding sheath was returned with the dilator partially inserted through the proximal fitting.The sheath was returned with a protective tube over the flexor tubing.The flexor tubing was separated 1 millimeter (mm) distal to the proximal hub and the coil is exposed.The sheath was tested for transition with the dilator and resistance was encountered.The dilator was removed from the sheath for further examination of the separation site.Slight accordion damage was noted to the sheath tubing.The dilator shaft is kinked.The dilator outer diameter measured within specification limits.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 no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints 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 peripheral intervention, the flexor high-flex ansel guiding sheath inner dilator would not advance into the sheath.The device did not come into contact with the patient.Another flexor high-flex ansel guiding sheath was used to successfully complete the procedure.According to the initial reporter, 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 sheath tubing was wrinkled and had begun to separate below the hub.The coiling was exposed, and the dilator shaft was noted to be kinked.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One flexor high-flex ansel guiding sheath was returned with the dilator partially inserted through the proximal fitting.The sheath was returned with a protective tube over the flexor tubing.The flexor tubing was separated 1 millimeter (mm) distal to the proximal hub and the coil is exposed.The sheath was tested for transition with the dilator and resistance was encountered.The dilator was removed from the sheath for further examination of the separation site.Slight accordion damage was noted to the sheath tubing.The dilator shaft is kinked.The dilator outer diameter measured within specification limits.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 no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however it is thought that package handling, product shipment and storage conditions are all possible.Appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 7213768
• Report Number: 1820334-2018-00194
• Device Sequence Number: 16440489
• Product Code: DYB
• UDI-Device Identifier: 00827002562301
• UDI-Public: (01)00827002562301(17)200825(10)8170872
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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-5.0-35-55-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1