MAUDE Adverse Event Report: HOLOGIC, INC. CONTURA MLB CATHETER WITH TRICONCAVE; CONTURA MLB SOURCE APPLICATION FOR BRACHYTHERAPY

Model Number B01245

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.If additional relevant information is received, a supplemental medwatch will be filed.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.Internal reference complaint#:(b)(4).

Event Description

Limited information was reported by a physician (b)(6) 2017: a physician performed a contura procedure for brachytherapy.The physician had a question regarding an "apparent allergic reaction.She has been performing balloon implants since 2003, and she has never seen an allergic reaction before".We have been unable to obtain additional information surrounding this event.

Manufacturer Narrative

This event was reported inadvertently.This product is latex free and there are no known allergic-type materials used within the device.It is unknown what gloves were used.There was no malfunction of our device and no serious injury.This event has been reassessed to not reportable.If additional information is received at a later date a supplement will be file.

• Brand Name: CONTURA MLB CATHETER WITH TRICONCAVE
• Type of Device: CONTURA MLB SOURCE APPLICATION FOR BRACHYTHERAPY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6958871
• MDR Text Key: 89630565
• Report Number: 1222780-2017-00255
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: B01245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2017
• 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
• Patient Outcome(s): Other