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U.S. Department of Health and Human Services

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

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COOK INC FLEXOR GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number G32373
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 that during implantation of another manufacturer's iliac stent graft, the surgeon tried to gain access back into the recently deployed stent as it had moved. Prior to re-insertion of the flexor guiding sheath, it was observed that the dilator had split; therefore, the sheath was not used. The sheath was reported to have been previously utilized. An angiogram, iliac stenting, and an angioplasty were performed; the case was able to be successfully completed. Another manufacturer's sheath followed by the flexor guiding sheath with check-flo valve, wire guide (manufacturer unspecified), and the iliac stent graft were utilized. Access to the aneurysm was gained via bilateral (right and left) groin puncher. The patient did not require any additional procedures due to this occurrence.   according to the initial reporter, 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, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed the presence of a 2 mm split at the tip of the device. No other damage was noted to the device. The dilator accepted a 0. 038¿ wre guide, but the split in the tip prevented a smooth transition. 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. 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 GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7306889
MDR Text Key101524807
Report Number1820334-2018-00559
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002323735
UDI-Public(01)00827002323735(17)200404(10)7800521
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,foreig
Type of Report Initial,Followup,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/04/2020
Device Model NumberG32373
Device Catalogue NumberKCFW-12.0-38-40-RB
Device Lot Number7800521
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/01/2018 Patient Sequence Number: 1
Treatment
PYRAMED BEGRAFT STENTAVANTI SHEATHWIRE GUIDE UNK
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