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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC
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COOK INC Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown.Occupation: non-healthcare professional.Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.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 an unknown procedure, an unknown cook sheath had a hole in the material.It was reported that the event was recognized quickly and the sheath was changed.It has not been reported that a section of the device remained inside the patient¿s body, that the patient required any additional procedures due to this occurrence, or that the patient experienced any adverse effects due to this occurrence.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
 
Manufacturer Narrative
Investigation - evaluation.Reviews of the complaint history, manufactures instructions, and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, based on the customer¿s description of the event, the returned device from (b)(4) will be used as a reference device.¿the visual inspection of the returned package confirmed one used rcfp-5.5-25-j was returned without the inner dilator for investigation.There was a 2mm crack in the sheath tubing just below the proximal fitting.The connecting cap and check-flo body were disassembled from the device to check the flare.The flare appeared to have been crushed in the fitting and had a crack down the side and extensive damage.Half of the flare was folded inward.The distal tip of the introducer was intact and there was no additional surface damage.The device was out of specification.¿ additionally a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.Investigation has determined that the conclusion codes for pr250659 & pr248484 would not be the same because without additional information it is not possible to determine if the device associated with pr2506559 was truly out of specification or if there were other unknown factors that contributed to that failure.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
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Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key8209649
MDR Text Key132077785
Report Number1820334-2019-00047
Device Sequence Number1
Product Code HIH
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
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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