MAUDE Adverse Event Report: GREATBATCH MEDICAL CAPELLA COAXIAL MICRO-INTRODUCER KIT; INTRODUCER, CATHETER

Model Number 1012868-006

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Event Description

As reported: upon opening the device packaging the bottom seal was partially opened.There was no patient contact.

Manufacturer Narrative

No device was returned for evaluation.Based on the description, it is assumed that this complaint is similar to that in mdr 2183787-2017-00090, and that a portion of the pouch was unsealed.A procedure review revealed that a 100% visual inspection of sealed pouches is done as part of the pouch sealing process.Specific inspections related to the pouch sealing defects include: incomplete sealing, missed sealing, misaligned sealing, wrinkles in the sealing area, voids, gaps or channels in sealing, contaminants that interfere with sealing, and perforations or holes in pouch.Review of product records for the complaint lot revealed no defects, ncmrs or deviations.A capa was initiated for this issue.The failure mode represented in the sample sent by the customer could not be reproduced.While the exact root cause could not be determined, possible root causes were identified.Corrective and preventive actions have been implemented and are detailed within the capa; e.G.Preventative maintenance and inspection procedural improvements.

• Brand Name: CAPELLA COAXIAL MICRO-INTRODUCER KIT
• 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: 6773460
• MDR Text Key: 82038004
• Report Number: 2183787-2017-00091
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 008213294000347
• UDI-Public: (01)008213294000347(17)190105(10)VN3629409
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D230851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2019
• Device Model Number: 1012868-006
• Device Catalogue Number: MK5183
• Device Lot Number: VN3629409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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