MAUDE Adverse Event Report: BOSTON SCIENTIFIC - LOWELL, MA VIKING?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number H3114000041

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2014

Event Type  malfunction  

Event Description

It was reported the sterile packaging was not completely sealed.A viking 6f,115cm,jos,4e,5mm catheter was selected.The outer box appeared " a little squashed" but internally, no obvious damage was noted.An attempt was made to open the catheter packaging; however, it was noticed that the catheter pouch was open already.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

(b)(4).Mfr site name: c.R.Bard (b)(4).It is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: VIKING?
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - LOWELL, MA; 55 technology drive; lowell MN 01851
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4298756
• MDR Text Key: 5083671
• Report Number: 2134265-2014-07706
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K971265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/08/2014

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
• Device Operator: Health Professional
• Device Model Number: H3114000041
• Device Catalogue Number: 400004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2014
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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