MAUDE Adverse Event Report: CREGANNA UNLIMITED COMPANY TRAPPER EXCHANGE DEVICE; CATHETER, PERCUTANEOUS

Model Number	H74939330130
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Inflated to 16atm on device while in a 6fr guide catheter.Trapper would not hold wire in place while attempting to remove micro catheter.

• Brand Name: TRAPPER EXCHANGE DEVICE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CREGANNA UNLIMITED COMPANY; 5905 trenton lane n; plymouth; minneapolis MN 55442
• MDR Report Key: 15657365
• Report Number: 15657365
• Device Sequence Number: 6387509
• Product Code: DQY
• UDI-Device Identifier: 05391526210154
• UDI-Public: (01)05391526210154(7)230828(10)3571029505
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2022
• Report Date (Section F): 10/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: H74939330130
• Device Catalogue Number: H74939330130
• Device Lot Number: 3571029505
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/05/2022