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

Catalog Number	412390406
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for return.As no product samples were returned for investigation, a probable cause cannot be identified based on the information that has been provided.Concomitant medical products: 8fr catheter, mfr st.Jude medical, repositioning sleeve, mfr st.Jude medical.
Event or Problem Description
The event involved a torque-line catheter, 7f, 4 lumen, 110 cm, heparin coated, lf, that during cardiac catheterization, the balloon ruptured in the patient.There was no reported difficulty noted during the insertion.It was also reported that an 8 fr.Catheter and repositioning sleeve was used during the procedure.They routinely perform a ¿balloon up¿ test shortly after it¿s taken out of the package by the fellow, who pre-inflates the balloon.There was no serious injury/harm, no adverse event, no medical intervention required and no delay in critical therapy.
Additional Manufacturer Narrative
H10 - medsun medwatch received.

• Brand Name: TD TORQUE-LINE 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: 8322038
• Report Number: 1713468-2019-00003
• Device Sequence Number: 2357475
• Product Code: DQE
• UDI-Device Identifier: 00840619043773
• UDI-Public: (01)00840619043773(17)190701(10)91-854-SL
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: 412390406
• Device Lot Number: 91-854-SL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1