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

Model Number	1000182-001
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned for evaluation.However, this issue was previously confirmed through events reported in 2183787-2017-00005 and 2183787-2017-00006.The malfunction was discovered prior to device use, and there was no impact to the patient.After pouches are sealed a 100% visually inspection is performed to verify the seal.The requirement for inspection of packaging prior to use is detailed in the ifu and is a standard surgical preparation practice.The root cause was attributed to inadequate process execution - and inadequate work environment.Recall is estimated to be issued to fda by 02/10/2017.Corrective actions are detailed in a capa and include adding performance based training, clarifying procedures, and adding a single piece flow at the pouch sealing and pouch seal verification work stations.
Event or Problem Description
It was reported that the sterile pouch wasn't closed.The device was replaced prior to use.

• 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: 6301554
• Report Number: 2183787-2017-00007
• Device Sequence Number: 735528
• Product Code: DYB
• UDI-Device Identifier: 10846835012385
• UDI-Public: (01)10846835012385(17)170606(10)W3455438
• 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: Medical Equipment Company Technician/Representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/10/2017

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: 06/01/2017
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: W3455438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1