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

Model Number	1000182-001-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "during svc isolation, phrenic nerve paralysis occurred during free wall ablation.Ablation was discontinued immediately, but paralysis did not return, and the patient left the room.Diaphragmatic nerve paralysis.The phrenic nerve palsy remained when the patient left the room.The physician commented that nothing in particular" no allegations were made against the mobicath sheath.

• Brand Name: MOBICATH BIDIRECTIONAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; plymouth MN 55441
• Manufacturer Contact: daniel gil de lamadrid ; 2300 berkshire lane; plymouth, MN 55441 ; 7639518209
• MDR Report Key: 13423797
• Report Number: 2183787-2022-00002
• Device Sequence Number: 5379551
• Product Code: DYB
• UDI-Device Identifier: 00821329400995
• UDI-Public: (01)00821329400995(11)210405(17)220405(10)GB6363457(20)12
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2022

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: 04/27/2021
• Device Model Number: 1000182-001-12
• Device Catalogue Number: D140010
• Device Lot Number: GB6363457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown