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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G13287
Device Problems Bent (1059); Material Separation (1562); Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

It was reported that a gunther tulip vena cava filter retrieval set was used to retrieve a celect platinum vena cava filter from an (b)(6) female patient. The filter was noted to have been implanted in the patient on (b)(6) 2017. The filter was able to be hooked; however, while attempting to advance the sheath over the filter with the coaxial sheath set, the filter hook bent over the snare (medwatch reference number will be provided when available) and the 11 fr sheath separated from its hub simultaneously. It was noted the tips of both sheaths were jagged/ bent/ cut. The physician attempted to remove the gunther tulip vena cava filter retrieval set to exchange it with a new set; however, the snare was unable to be removed due to the bent filter hook, and the set had to be completely dismantled to remove all of the parts. The snare was left inside of the patient's anatomy at this point. Another retrieval set was opened and flushed; however when the physician pulled on the hub, it separated from the sheath and was therefore unable to be used to continue the procedure (refer to medwatch 1820334-2017-04627). This did not make patient contact. Another manufacturer's sheath was utilized to successfully complete the filter retrieval. A section of the devices used did not remain inside the patient¿s anatomy. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. The patient was noted to experience slightly-above normal blood loss due to the quantity of devices changed out, however there was no concern from the physician, and no additional intervention was required. A normal post-venogram was observed.

 
Manufacturer Narrative

Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed that the hub had slipped the flare of the introducer sheath. However, a similar test fitting was attached to the complaint sheath, and even after strong pull forces were exerted on the device, the fitting did not slip the sheath. 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 was one other reported complaint 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.

 
Manufacturer Narrative

Additional information: refer to medwatch 3002808486-2018-00038 with regards to the filter hook which bent over the gunther tulip vena cava filter retrieval set snare during the procedure. Refer to medwatch 1820334-2017-04626 and 1820334-2017-04627 as both sheaths had tips that were jagged/ bent/ cut. This event is currently under investigation. A supplemental report will be provided upon conclusion.

 
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Brand NameGUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7151485
MDR Text Key96235673
Report Number1820334-2017-04626
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG13287
Device Catalogue NumberGTRS-200-RB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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