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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported during a recanalization of arteriosclerosis obliterans procedure using a flexor raabe guiding sheath, the sheath was separated from the hemostasis valve.The end user finished the procedure with another new device.The section of the device did not remain in the patient's body and the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, dimensional verification, device history record, documentation, drawings, manufacturers instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One used flexor raabe guiding sheath with dilator was returned for evaluation.The sheath tubing was noted to be tubing from the hub.No other notable damage was observed.The connector cap accepted a 0.138" pin gauge and the sheath flare passed through larger setting but did not pass through the smaller setting.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.Based on the information provided and results of the investigation, a definitive root cause could not be determined.Per the risk assessment no further action is require we will continue to monitor for similar complaints.
Event or Problem Description
It was reported that during the recanalization of occlusive arterial disease procedure of the lower limb the flexor raabe guiding sheath separated from the hemostatic valve.A new device was used to completed the procedure.A section of the device did not remain in the patient and there were no reported adverse events.

• 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: 6576602
• Report Number: 1820334-2017-00875
• Device Sequence Number: 11011637
• Product Code: DYB
• UDI-Device Identifier: 00827002116344
• UDI-Public: (01)00827002116344(17)190211(10)6729219
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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 Model Number: N/A
• Device Catalogue Number: KCFW-7.0-38-90-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1