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	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned pouch confirmed the bottom end of the pouch was not sealed.No indentation from the pouch sealer was observed and there was no indication that the pouch end was cut off.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 upon opening the packaging, the top of the packaging was not sealed properly; the device was replaced.

• 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: 6301548
• Report Number: 2183787-2017-00005
• Device Sequence Number: 19234884
• Product Code: DYB
• UDI-Device Identifier: 10846835012385
• UDI-Public: (01)10846835012385(17)170606(10)W3459354
• 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): 10/12/2016

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: 06/06/2017
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: W3459354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• 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