MAUDE Adverse Event Report: COOK INC FLEXOR RADIAL ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product was received and a visual inspection was conducted.A review of the complaint history, device history record, ifu and quality control of the reported device was conducted.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.A review of the complaint history, device history record, specifications, quality control and visual inspection of the returned devices was conducted.The returned device was visually inspected.It is possible that the root cause of the event could be related to the distal tip of the sheath not being ground/tapered enough.Also, it is possible that other factors, such as patient condition could have contributed to the complaint.A definitive root cause cannot be determined.
Event or Problem Description
It was reported that during a radial access coronary diagnostic procedure using a flexor radial access set, upon insertion, the sheath flowered back at the transition point.The device was removed and a competitor's device was used successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, manufacturing instructions, quality control, inspection of unused product, and visual inspection of the returned device was conducted during the investigation.One used device was returned.Inspection found the sheath tip to be wrinkled and damaged.A closer look at the tip found there was no taper, the sheath had not been tipped.When using magnification, the distal end of the sheath was found to be textured, suggesting that it had been ground.Due to the damaged condition of the used complaint device, an accurate measurement could not be obtained for the length of the textured section.Review of the device history record 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 required.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR RADIAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6611609
• Report Number: 1820334-2017-01226
• Device Sequence Number: 531285
• Product Code: DYB
• UDI-Device Identifier: 00827002356009
• UDI-Public: (01)00827002356009(17)190309(10)6647688
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

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: KCFN-5.0-18-13-RA-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2016
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1