MAUDE Adverse Event Report: ICU MEDICAL, INC. TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number 412290402

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation.It is yet to be received.

Event Description

The event involves a td thermodilution catheter that ruptured while the balloon was being inflated in the cath lab.There was no patient involvement, no medication involved, no human harm, no adverse event and no delay in critical therapy.

Manufacturer Narrative

H10 - section d10 - device returned to manufacturer on april 26, 2019.Received one (1) used, list # 412290402, td catheter, 7f, 4 lumen, 110 cm, heparin coated, lf; lot # 90-997-sj.The reported complaint of a balloon rupture was confirmed.The returned td catheter was received with the balloon ruptured with part of the balloon flipped inside out around the tip of the catheter.No portion of the balloon appears to be missing.The observed damage is typical of damage seen while using a introducer or contamination shield which is too small.One source of this type of physical damage to the balloon could be from an outside influence such as a contamination shield or an introducer sheath.Ensure any introducer or contamination shield used is designed for the proper french size of the catheter per the directions for use (dfu), which states the french size should be one size larger than the catheter.Without the return of the used introducer or shield, the cause of the physical damage cannot be determined.The lot # 90-997-sj was reviewed and there were no relevant non-conformances found.

• Brand Name: TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• MDR Report Key: 8425415
• MDR Text Key: 139039311
• Report Number: 1713468-2019-00010
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00840619043650
• UDI-Public: (01)00840619043650(17)190701(10)90-997-SJ
• Combination Product (y/n): N
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

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 Expiration Date: 07/01/2019
• Device Catalogue Number: 412290402
• Device Lot Number: 90-997-SJ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1