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

Model Number 1000182-001

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

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 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• Manufacturer Contact: rhonda stager ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518376
• MDR Report Key: 6301548
• MDR Text Key: 66558430
• Report Number: 2183787-2017-00005
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835012385
• UDI-Public: (01)10846835012385(17)170606(10)W3459354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1