MAUDE Adverse Event Report: GREATBATCH MEDICAL; MOBICATH BIDIRECTIONAL GUIDING SHEATH, SMALL CURVE,

Model Number	1000182-001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Mobicath sheath has sucked in air during the aspiration process.No patient consequence.

• Common Device Name: MOBICATH BIDIRECTIONAL GUIDING SHEATH, SMALL CURVE,
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis, mn
• MDR Report Key: 9946867
• Report Number: 2183787-2020-00039
• Device Sequence Number: 16337881
• Product Code: DYB
• UDI-Device Identifier: 10821329400992
• UDI-Public: (01)10821329400992(17)201111(10)GB5137623
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2020

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 Expiration Date: 11/11/2020
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: GB5137623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 03/17/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/26/2020; 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1