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

Catalog Number	601296
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.(b)(4).One used balloon catheter set without packaging and one used terumo 12 cc "single use syringe" was returned for evaluation.Visual examination of the set noted no visual issues.The syringe was examined and it was noted some liquid was still inside the syringe.The air line of the device was accessed using a omnifix syringe filled with 1.5 cc of air.The balloon was inflated, however the balloon could not deflate.An occlusion test was performed per specification.The guide wire passed fully through the devices with no issues noted, passing the occlusion test.The device was sectioned off starting from the distal end, and the air balloon line examined during each sectioning.When the molded manifold section was sectioned, liquid was noted to be present inside the air balloon line.The cut molded manifold section was examined under the ram optical, and confirmed liquid to be present inside the air balloon line.However, there was note enough liquid inside the air balloon line to test.The liquid found inside air balloon line prevented the balloon catheter from deflating.Incidents of this nature are consistent with incorrect user interaction with the product.Per the instructions for use (ifu), "do not use liquids as a balloon inflation media".Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.Note: this case is being filed retrospectively as a result of a review of recent customer complaint information.Based on additional information and details provided in another complaint case, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of a similar nature in accordance with internal procedure (b)(4).
Event or Problem Description
As reported by user facility: balloon catheter was inserted to obtain a cs venogram.The balloon cannot be deflated.The physician decided to inject more air to the balloon catheter and the balloon ruptured.No patient injury.

• 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: 6208715
• Report Number: 2523676-2016-00898
• Device Sequence Number: 323066
• Product Code: DYG
• UDI-Device Identifier: 04046964325823
• UDI-Public: (01)04046964325823(17)170131(10)0061384742
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K822806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2016

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: 01/31/2017
• Device Catalogue Number: 601296
• Device Lot Number: 0061384742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2016
• Initial Report FDA Received Date: 12/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1