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U.S. Department of Health and Human Services

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

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COOK INC FLEXOR RTPS GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 510k status: preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
The customer reported that, when the package of the flexor rtps guiding sheath was opened for a transjugular liver biopsy, it was discovered that the dilator that was included with the introducer had an irregular tip; there appeared to be a split in the tip of the device. The operator attempted to introduce it through the skin of the patient, but subsequently ran into unspecified difficulties. The operator replaced the product with a new device, and no further issues were reported. No anatomical abnormalities were noted at the access site. The customer confirmed that no patient adverse events resulted from the product problem, and no additional procedures were necessitated. The complaint device is reportedly unavailable for return and evaluation.
 
Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and specifications of the device was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed. However, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The appropriate manufacturing documents from the device master record (dmr) pertaining to the reported failure mode were reviewed, revealing no notable gaps in the manufacturing process. Documentation indicates to confirm the distal tip of the dilator is rounded, smooth, free of excessive nicks and debris, and to reject the product if any splits are noted. A review of the 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. There is no evidence confirming this failure was manufacturing related or shipping/handling related. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints and have notified the proper personnel about this event. Per the quality engineering risk assessment no further action is required.
 
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Brand NameFLEXOR RTPS GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7390814
MDR Text Key104411677
Report Number1820334-2018-00858
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
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 03/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberKCFW-10.0-35-RB-RTPS-100
Device Lot Number8538789
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No

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