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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The flexor ansel guiding sheath was returned for evaluation.Visual inspection of the device revealed that the tip was nicked.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.It is unlikely that the deformed tip was introduced during the manufacturing process.It is possible that the dilator distal tip became damaged during shipping or handling.Based on the information provided and results of the investigation it is unlikely that the deformed tip was a result of the manufacturing process.The most likely root cause of the reported event may be related to damage sustained to the distal tip of the dilator during shipping or handling; however, this cannot be conclusively determined.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
During the course of investigation of the flexor ansel guiding sheath, it was noted that the material on the tip of the dilator was nicked.The customer had complained that prior to use the dilator was noted to be kinked and could not be used for the procedure.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The device was returned for evaluation.The device failure analysis revealed that the distal tip of the dilator was nicked.A device history record review of the finished product shows no nonconforming events that would contribute to this failure mode.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 could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
An international customer reported that upon opening the package, the dilator was kinked.Another one from a different lot was used for the procedure.Further investigation revealed that the distal tip of the first dilator was nicked.

• 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: 6612763
• Report Number: 1820334-2017-01227
• Device Sequence Number: 10925124
• Product Code: DYB
• UDI-Device Identifier: 00827002299993
• UDI-Public: (01)00827002299993(17)190420(10)6903349
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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 Model Number: N/A
• Device Catalogue Number: KSAW-7.0-18/38-55-RB-ANL1-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1