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

Model Number	1000182-001
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A catheter was returned for analysis.Visual inspection of the returned catheter confirmed the sideport was detached.Further visual inspection found the molded sideport arm, sideport, and strain relief fractured off of the molded hub.Review and confirmation of manufacturing records was performed.The sideport tubing is inserted into a molded sideport on the hub.The sideport adhesive is 100% visually inspected by a certified associate to ensure the adhesive coverage meets requirements.Following sideport cure, a strain relief is installed with adhesive over the molded sideport arm and sideport tube to further insure adequate bonding.Also the inspection procedure requires that units are 100% visually inspected for damage to the sideport.In addition all units are 100% functionally tested for leak.All records indicate the device met specification to leaving greatbatch.Greatbatch is unable to verify the root cause.Device analysis indicates the catheter met specification requirements.It is believed that the sideport was damaged during use causing it to fracture from the molded hub.Due to the low occurrence rate (1st occurrence) and investigation indicating the device met specification at the time of shipment and was damaged during use, no corrective action will be taken at this time.
Event or Problem Description
It was reported that the side port on the mobi catheter fell off of the sheath.The physician replaced the product and continued with the case.

• 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: 5815980
• Report Number: 2183787-2016-00062
• Device Sequence Number: 19006010
• Product Code: DYB
• UDI-Device Identifier: 10846835012385
• UDI-Public: (01)10846835012385(17)170222(10)W3359665
• 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
• Type of Report: Initial
• Report Date (Section B): 06/22/2016

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: No Information
• Device Expiration Date: 02/22/2017
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: W3359665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2016
• Initial Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention