MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CORONARY SINUS BALLOON VENOGRAPHY CATH; CATHETER, FLOW DIRECTED

Catalog Number	601296
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: catheter balloon unable to initiate.No patient injury.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical (b)(4).One used catheter without packaging was returned for evaluation.Visual examination of the catheter noted a small laceration or cut in the balloon of the catheter.A syringe was attached to the catheter in order to inflate the balloon with failing results.The returned catheter confirmed the reported defect of catheter balloon unable to initiate.House retain samples were pulled for evaluation.Visual examination of the balloon catheter noted no visual defects.The balloon catheter was engaged using a 1.25 cc controlled stroke syringe.The balloon inflated with no issues noted.Based on the results of the sample evaluation, no specific conclusions can be made regarding the cause of the reported event.Every catheter is 200% inspected during manufacturing so the damage is believed to have happened between packaging and when the doctor inflated the balloon.The balloon is delicate and can be damaged by contact with a variety of sharp objects and rough surfaces.No further corrective/preventative action is warranted at this time.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: CORONARY SINUS BALLOON VENOGRAPHY CATH
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6446129
• Report Number: 2523676-2017-00041
• Device Sequence Number: 682032
• Product Code: DYG
• UDI-Device Identifier: 04046964325823
• UDI-Public: (01)04046964325823(17)150831(10)0061301571
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K822806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 601296
• Device Lot Number: 0061301571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1