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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number 2404-03
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported foreign matter was present.When the comet ii pressure guidewire was going to be used, the nurse found a thread-like foreign object inside the sterile bag.Therefore, the device was not used.The procedure was successfully completed with a different device without further issue or patient injury.
 
Event Description
It was reported foreign matter was present.When the comet ii pressure guidewire was going to be used, the nurse found a thread-like foreign object inside the sterile bag.Therefore, the device was not used.The procedure was successfully completed with a different device without further issue or patient injury.
 
Manufacturer Narrative
E1: initial reporter city: (b)(6).Device returned to manufacturer: returned product consisted of the sealed comet ii product pouch with the comet device inside.The packaging was visually and microscopically examined.Inspection of the device revealed there was a 7mm piece of fm (foreign material) in the bottom left corner of the sealed product pouch.To determine what kind of material the fm was in the pouch, further analysis was conducted by using the ftir.The pouch was opened, and the fm was removed and placed in the ftir and tested.After ftir analysis of the fm within the sealed pouch; it was observed to be spectrally similar to a cellulose material within our spectral library.Cellulose is a known material that is used in paper and cardboard materials.Product analysis confirmed the reported event, as there was fm in the sealed product pouch.
 
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Brand Name
COMET II
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12192258
MDR Text Key262434929
Report Number2134265-2021-09073
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/02/2023
Device Model Number2404-03
Device Catalogue Number2404-03
Device Lot Number0027078528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2021
Initial Date Manufacturer Received 06/24/2021
Initial Date FDA Received07/19/2021
Supplement Dates Manufacturer Received07/23/2021
Supplement Dates FDA Received07/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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