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	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and is pending investigation.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: the reported complaint was verified.A latex free balloon of the td catheter was torn radially around the balloon with the top half flipped inside-out.The balloon also appeared to have failed while inflated with the latex free balloon material being stretched out.The cause of the ruptured balloon cannot be determined.No contamination shield was returned with the sample.Unused samples were received and tested and physical damage was observed on all of the balloons inserted into the repositioning sleeve where the cath-lock was tightened to 0.067" with the inflation cycle count decreasing on the sample when compared to a control sample.The probable cause of the balloon ruptures are due to inserting them through a mating device such as a repositioning sleeve or introducer with a smaller inner diameter than the balloon's outer diameter.This caused undue stress on a portion of the balloon as the balloon is stretched back and folds over.The lot review was performed and there were no issues identified.

• 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: 8344738
• Report Number: 1713468-2019-00005
• Device Sequence Number: 13789620
• 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: User Facility
• 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?: Yes
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1