MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BALLOON CATHETER RUSCH 100% SILICONE

Catalog Number MEDICAL UNKNOWN

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the balloon could not be deflated.The device was removed with the balloon inflated.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Report 8040412-2019-00376 device identification has been updated as balloon catheter rusch 100% silicone.However, the catalog number remains unknown.One piece of the actual sample was returned for investigation.Based on the complaint description it was reported that the balloon could not be deflated.Further investigation was conducted by inflating the sample with 10ml of water.It was noticed that the balloon was asymmetry and the balloon ratio did not meet the acceptable limit for balloon asymmetry.The sample was then subjected to deflation test using an empty syringe without plunger.However, it was found that the balloon could not be fully deflated as experienced by the complainant.Non deflation might be due to the asymmetrical condition of the balloon which resulted in occlusion of the inflation lumen eye during deflation process.Other remarks: based on experience, balloon asymmetry could happen due to uneven balloon wall thickness, or uneven bonding length.Further investigation and corrective action will be addressed through an nc.In conclusion, after investigation, it was noticed that the balloon was asymmetry where the balloon ratio did not meet the acceptable limit for balloon asymmetry.During deflation test, it was found that the balloon could not be fully deflated as experienced by the complainant.Non deflation might be due to the asymmetrical condition of the balloon which resulted in occlusion of the inflation lumen eye during deflation process.

• Brand Name: BALLOON CATHETER RUSCH 100% SILICONE
• Type of Device: BALLOON CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9512798
• MDR Text Key: 177796490
• Report Number: 8040412-2019-00376
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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 Catalogue Number: MEDICAL UNKNOWN
• Device Lot Number: UNKN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1