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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL NSP BULK NON-STERILE, 8FR, 13CM INTRODUCER, CATHETER

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GREATBATCH MEDICAL OPTISEAL NSP BULK NON-STERILE, 8FR, 13CM INTRODUCER, CATHETER Back to Search Results
Model Number 1002636-003
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Laceration(s) (1946)
Event Date 08/17/2021
Event Type  Injury  
Event Description
An interventional radiology lead technician reported an issue with a 8f low profile plastic vortex port detached poly catheter filled sh valved introducer. During a procedure, the physician was implanting the port into a patient, and as the sheath was being peeled, it cut the doctor on his finger. The procedure was completed with this device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident. The doctor required blood tests after the cut. Further clarification from the customer indicated there was an allegation that the device was difficult to split, and required more pressure than normal.
 
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Brand NameOPTISEAL NSP BULK NON-STERILE, 8FR, 13CM
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
GREATBATCH MEDICAL
2300 berkshire lane
minneapolis MN 55441
MDR Report Key12669160
MDR Text Key281401354
Report Number2183787-2021-00092
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K093232
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002636-003
Device Lot NumberW5180762
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1
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