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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER SP KIT, 5 PACK, 6FR, 13CM; INTRODUCER, CATHETER

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GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER SP KIT, 5 PACK, 6FR, 13CM; INTRODUCER, CATHETER Back to Search Results
Model Number 1000093-001
Device Problems Fracture (1260); Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Event Description
Wing broke off and unable to split sheath as per normal.Used hemostat to grab edge of sheath and split using wing that was still attached.
 
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Brand Name
OPTISEAL VALVED PTFE PEELABLE INTRODUCER SP KIT, 5 PACK, 6FR, 13CM
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
GREATBATCH MEDICAL
2300 berkshire lane
minneapolis MN 55441
Manufacturer Contact
samuel master
2300 berkshire lane
minneapolis, MN 55441
7639518115
MDR Report Key12579993
MDR Text Key274990410
Report Number2183787-2021-00085
Device Sequence Number1
Product Code DYB
UDI-Device Identifier0082132900579
UDI-Public(01)0082132900579(11)210519(17)230519(10)W6235329
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/05/2021
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 Date05/19/2023
Device Model Number1000093-001
Device Catalogue NumberN/A
Device Lot NumberW6235329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Initial Date Manufacturer Received 09/08/2021
Initial Date FDA Received10/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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