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

Model Number	1000182-001
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Type of Reportable Event	Serious Injury
Event or Problem Description
Detailed circumstances at the time of occurrence (always stated if an error code is known): when the wire and the catheter were inserted into the la, the blood pressure dropped.When it was confirmed on echocardiography,drainage was performed because pericardial fluid had accumulated.Ablation stopped.Timing when complaint occurred: after bb, when the catheter was approached to the la.How the procedure was completed: the procedure was stopped.After drainage was conducted, the blood pressure was stable, when the patient left, their condition was stable.The physician commented that, after bb, wire and the catheter approach, it was likely that the wire (or catheter) were inserted strongly in the direction of the left atrial appendage, which might be the cause.

• Brand Name: MOBICATH BIDIRECTIONAL GUIDING SHEATH, SMALL CURVE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 8800333
• Report Number: 2183787-2019-00058
• Device Sequence Number: 2839129
• Product Code: DYB
• UDI-Device Identifier: 10821329400992
• UDI-Public: 10821329400992
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2019
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: GB4680967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1