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U.S. Department of Health and Human Services

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

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COOK INC FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number G11638
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable. (b)(4). Pma/510(k) number
=
pre-amendment. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported the flexor raabe guiding sheath split during an unspecified vascular procedure. A section of the device did not remain inside the patient¿s body. According to the initial reporter, no additional procedures and/or interventions were required. The patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed that the sheath tubing was separated into 8 segments. Segments 1, 2, and 3 were connected by exposed coil. Segments 6, 7, and 8 were also connected by exposed coil. There were 4 compressions noted on segment 4; three of the compressions were 4 mm in length, and one compression was 3 mm in length. There was a 5 mm split on segment 5. Eight compressions, each 2 mm in length, were noted on segment 6, and six 2 mm compressions were noted on segment 8. Additionally, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. A review of the device history record showed 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, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined. Measures are being conducted to address this failure mode. We will continue to monitor for similar complaints. Per the quality engineering risk assessment, no further action is required.
 
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Brand NameFLEXOR RAABE GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7425741
MDR Text Key105772563
Report Number1820334-2018-00908
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/16/2018
Device Model NumberG11638
Device Catalogue NumberKCFW-6.0-38-55-RB-RAABE
Device Lot Number6292162
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No

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