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

Catalog Number	412290402
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for investigation.It is yet to be received.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• MDR Report Key: 8425415
• Report Number: 1713468-2019-00010
• Device Sequence Number: 16695693
• Product Code: DQE
• UDI-Device Identifier: 00840619043650
• UDI-Public: (01)00840619043650(17)190701(10)90-997-SJ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1