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	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It is yet to be received.
Event or Problem Description
It was reported that during cardiac catheterization the balloon of the td torque-line catheter, 7f, 4 lumen, 110 cm, heparin coated, lf ruptured during insertion.There was patient involvement, but no adverse event, no delay in critical therapy, nor medical/surgical intervention required.The device was changed with no further problems encountered.No additional information provided.
Additional Manufacturer Narrative
One (1) used, list # 412390406, td torque-line catheter, 7f, 4 lumen, 110 cm, heparin coated, lf, lot # 92-324-he was received for evaluation.The reported complaint of a ruptured balloon was confirmed.As received, the latex free balloon of the td catheter was balloon was torn.The balloon appears to have failed while inflated with the latex free balloon material being stretched out.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 # 92-324-he was reviewed and there were no relevant non-conformances 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: 8432833
• Report Number: 1713468-2019-00011
• Device Sequence Number: 19336696
• Product Code: DQE
• UDI-Device Identifier: 00840619043773
• UDI-Public: (01)00840619043773(17)190801(10)92-324-HE
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 08/01/2019
• Device Catalogue Number: 412390406
• Device Lot Number: 92-324-HE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1