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	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the event has been received however the investigation has not yet been completed.As additional information is obtained, a supplement report will be submitted.
Event or Problem Description
The reporter stated, during a cardiac catheterization the balloon ruptured.It was also reported that the customer has not made any changes to their sheath supplier or type and they routinely perform a ¿balloon up¿ test shortly after it¿s taken out of the package.Although there was patient involvement, there was no serious injury/harm, no adverse event, no medical intervention required and no delay in critical therapy reported.
Additional Manufacturer Narrative
The reported complaint of a ruptured balloon was confirmed.As received, the latex free balloon of the td catheter was torn.The balloon also appeared to have failed while inflated with the latex free balloon material being stretched out.Testing was completed on three new td torque-line catheters.Physical damage was observed on all three balloon catheters that were inserted into the sleeve with a smaller inner diameter.The probable cause of the balloon ruptures are due to inserting them through a mating device such as a re-positioning 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.A device history review (dhr) was performed and relevant commodities were reviewed and there were no relevant non-conformances found.G1: (b)(6).

• 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: 8307571
• Report Number: 1713468-2019-00001
• Device Sequence Number: 1063897
• Product Code: DQE
• UDI-Device Identifier: 00840619043773
• UDI-Public: (01)00840619043773(17)190301(10)85-294-SJ
• 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): 01/25/2019

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: 03/01/2019
• Device Catalogue Number: 412390406
• Device Lot Number: 85-294-SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1