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

Catalog Number	KCFW-4.0-35-55-RB-RAABE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.Investigation - evaluation: a review of the manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported only one of the two products was returned.A physical examination of the product was conducted.The dilator was found to be advanced into the sheath and the valve/cap was detached from the sheath.The dilator was withdrawn from the sheath.It was observed that the sheath flare was uneven and part of the flare had markings where the threading on the cap and valve had tightened down on the sheath material.When trying to unscrew by hand, it was noticed that the cap was still tightly screwed onto the valve.To determine if glue was present on the cap threads, pliers were clamped down on the knurls of the cap in several locations.Each time the pliers were clamped, there was an audible popping noise of the glue releasing from the threads.This indicated that the glue was present.The cap was removed from the check-flo body to determine if any detached sheath material was retained in the device.No pieces of the sheath material were observed/retained in either the check-flo body or cap.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the information provided, and the detection activities have been conducted, the reason for this failure cannot be determined.However, the sheath was confirmed to have separated from the valve.
Event or Problem Description
It was reported by the user facility that a patient underwent an sfa angioplasty procedure.The attending physician attempted to introduce the flexor raabe guiding sheath twice.When the physician put the dilator in the sheath, the valve was not glued to the sheath and it detached itself.No pieces from the broken basket were left in the patient nor did the patient experience any adverse effects or medical intervention due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.Investigation - evaluation: a review of the manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.One flexor raabe guiding sheath was returned to assist in the investigation.A physical examination of the product was conducted.The dilator was found to be advanced into the sheath and the valve/cap was detached from the sheath.The dilator was withdrawn from the sheath.It was observed that the sheath flare was uneven and part of the flare had markings where the threading on the cap and valve had tightened down on the sheath material.When trying to unscrew by hand, it was noticed that the cap was still tightly screwed onto the valve.To determine if glue was present on the cap threads, pliers were clamped down on the knurls of the cap in several locations.Each time the pliers were clamped, there was an audible popping noise of the glue releasing from the threads.This indicated that the glue was present.The cap was removed from the check-flo body to determine if any detached sheath material was retained in the device.No pieces of the sheath material were observed/retained in either the check-flo body or cap.There is no evidence to suggest the finished product was not made to specifications.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 risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported by an international user facility that a patient underwent a superficial femoral artery angioplasty procedure.The attending physician attempted to introduce the flexor raabe guiding sheath twice.When the physician put the dilator in the sheath, the valve was not glued to the sheath and it detached itself.No pieces from the broken basket were left in the patient nor did the patient experience any adverse effects or medical intervention due to this occurrence.No further information was provided.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6291788
• Report Number: 1820334-2017-00235
• Device Sequence Number: 10965227
• Product Code: DYB
• UDI-Device Identifier: 00827002481879
• UDI-Public: (01)00827002481879(17)170827(10)5243343
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

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-4.0-35-55-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1