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

Catalog Number	KCFW-5.0-18/38-45-RB-ANL0-HC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation - evaluation: a review of the drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The flexor ansel guiding sheath was returned to the manufacturer for evaluation.Visual inspection of the dilator confirmed that the distal tip of the dilator was damaged in such a manner that the 0.0038 wire could not be advanced.Additionally, kinks in the shaft material were found at 2.0 centimeters (cm), 8.5 cm, and 26.0 cm, measuring from the distal end of the proximal fitting.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 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 device is shipped with instructions for use (ifu) that outlines packaging & storage instructions: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred".Based on the information provided and the results of the investigation, a definitive root cause could not conclusively be determined.Factors that may have contributed may be related to shipping and handling processes of the device.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
It was reported that during peripheral intervention the medical team opened the flexor ansel guiding sheath and noted the tip to be pinched off.The wire would not thread through the introducer.The device was not used for the procedure.The reported event occurred prior to patient contact.The manufacturer's device evaluation results confirmed the damage to the tip of the complaint device.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used 0.038" endhole dilator was returned from a flexor ansel guiding sheath set.The distal tip of the dilator was compressed (approximately 90% closure).Kinks are noted at 8.5 cm and 26.0 from the proximal end.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 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 device is shipped with instructions for use (ifu) that outlines packaging & storage instructions: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.It is possible that the device was damaged during the shipping and handling process.However, based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 6639026
• Report Number: 1820334-2017-01229
• Device Sequence Number: 11089156
• Product Code: DYB
• UDI-Device Identifier: 00827002441538
• UDI-Public: (01)00827002441538(17)181207(10)6431893
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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-5.0-18/38-45-RB-ANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1