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

Catalog Number	KCFW-8.0-38-55-RB-RAABE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Initial information received on (b)(6) 2016: the hub separated from the sheath.No additional information was provided at this time.Additional information received on 08mar2016 determined this event to be reportable: the patient is reported to have had a calcified groin and the procedure lasted approx.An hour.Upon removal of the sheath, the flexor portion of the sheath separated from the hub.Fortunately the sheath was still able to be removed safely.It is unknown if the bifurcation was tortuous bifurcation or not.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation, a visual inspection, along with a review of the complaint history, quality control, dimensional verification, specifications, manufacturing instructions, and trends of the returned used and damaged product was conducted.One used sheath and dilator was returned to assist in the investigation.Visual inspection showed that the check-flo valve was separated from the hub when the device was received.A go/no go gage was used to confirm the flare was of adequate size.One side of the flare was slightly distorted indicating the flare was securely seated in the cap and check-flo assembly.The device is supplied with an ifu; which includes the warning," before withdrawing the sheath through the tortuous anatomy, insert the introducer dilator to avoid possible breakage." the integrity of this device is verified throughout the manufacturing process.Based on the information provided and the results of the investigation it is feasible to suggest the device met resistance beyond its intended design.We will continue to monitor for similar complaints.Per the health risk assessment (hra) no further action is required.
Event or Problem Description
Initial information received on (b)(6) 2016: the hub separated from the sheath.No additional information was provided at this time.Additional information received on (b)(6) 2016 determined this event to be reportable: the patient is reported to have had a calcified groin and the procedure lasted approx.An hour.Upon removal of the sheath, the flexor portion of the sheath separated from the hub.Fortunately the sheath was still able to be removed safely.It is unknown if the bifurcation was tortuous bifurcation or not.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 5535653
• Report Number: 1820334-2016-00189
• Device Sequence Number: 16205653
• Product Code: DYB
• UDI-Device Identifier: 00827002122420
• UDI-Public: (01)00827002122420(17)171215(10)5516001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2016

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-8.0-38-55-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2016
• Device Age: 14 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Supplement Report FDA Received Date: 06/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1