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	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
Towards the end of the angiogram (angioplasty on leg) procedure (at the stages of closing), the check-flo valve completely separated from the flexor raabe guiding sheath during removal.Another manufacturers 7x11 short sheath was used to complete the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Withdraw the sheath and dilator as a unit.Upon removal from package, inspect the product to ensure no damage has occurred.¿ work instructions for flaring: "verify flare size and adequacy: flare should be free of splits, nicks, pits, holes, kinks, and creases.Flare should be a concentric shape, not slanted or uneven; it should look like a champagne glass.Flare inside diameter should be unobstructed and round.Inside diameter should be free of debris, material flaps, strands, and protruding wires.Flare should fit over nose of adapter but not up onto adapter threads.When pulling flare down into base of cap, the flare should sit well in base of cap.You should not be able to pull the flare through the base of cap without wrecking or grossly distorting the flare.If flare is inadequate, determine if bad flare can be trimmed off and reflared.Cool iron using compressed air before reflaring or flaring next piece of tubing.Slight imperfection or ¿clutter¿ may be smoothed out by heating a checker wire or other tool and applying carefully to tubing, as long as flare integrity is not compromised" the visual inspection of the returned device reported one used/damaged device with the hub separated from the sheath.The flare was found to be slightly stretched, and stress marks were observed on the interior of the flare.A go no-go flare gauge was used to verify that the size of the flare met specification.It is feasible to suggest that the failure mode was caused by the device receiving force beyond its intended design during the removal process.The complaint device was returned therefore, investigation evaluation was 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 the results of our investigation, the root cause was determined to be product received excessive pressure.¿product use or handling related¿ we will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Event or Problem Description
Towards the end of the angiogram (angioplasty on leg) procedure (at the stages of closing), the check-flo valve completely separated from the flexor raabe guiding sheath during removal.Another manufacturers 7x11 short sheath was used to complete the procedure.A section of the device did not remain inside the patient¿s body.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: 5875641
• Report Number: 1820334-2016-00854
• Device Sequence Number: 10873167
• Product Code: DYB
• UDI-Device Identifier: 00827002116351
• UDI-Public: (01)00827002116351(17)190302(10)6782490
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2016

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 Model Number: N/A
• Device Catalogue Number: KCFW-7.0-38-70-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1