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

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

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 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.

Manufacturer Narrative

H10 - medsun medwatch received.

• Brand Name: TD TORQUE-LINE 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: 8322038
• MDR Text Key: 137022538
• Report Number: 1713468-2019-00003
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00840619043773
• UDI-Public: (01)00840619043773(17)190701(10)91-854-SL
• 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: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 412390406
• Device Lot Number: 91-854-SL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1