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	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is in progress.
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.There was unknown patient involvement, no report of a serious injury/harm, no report of an adverse event, and no report of delay in critical therapy.
Additional Manufacturer Narrative
The product was returned and tested.The complaint of a ruptured balloon was confirmed.Testing was performed and physical damage was observed on a balloon inserted into 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.A lot review was performed and no issues were found.

• 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: 8401857
• Report Number: 1713468-2019-00008
• Device Sequence Number: 1975915
• Product Code: DQE
• UDI-Device Identifier: 00840619043773
• UDI-Public: (01)00840619043773(17)190501(10)89-448-JW
• 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): 02/15/2019

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: 05/01/2019
• Device Catalogue Number: 412390406
• Device Lot Number: 89-448-JW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1