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	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.Testing and investigation is not complete.
Event or Problem Description
The event involved a torque-line catheter that the customer reported the catheter balloon ruptured during insertion or during patient use.A pre-insertion inflation test was done before the catheter was inserted and the balloon was intact.There was patient involvement, however there was no report of human harm, no adverse event, no medical or surgical intervention, and no delay in critical therapy.This captures the second of seven devices.
Additional Manufacturer Narrative
H10: received one used 412390406 td torque-line catheter, 7f, 4 lumen, 110 cm, heparin coated, lf lot#91-462-y1.A visual inspection of the sample showed the balloon ruptured and the sample was received with a portion of the balloon missing.The catheter was not returned with the contamination shield or introducer; therefore, the location of the missing piece of latex free material could not be determined.The returned mating devices were each microscopically examined for potential snag points that could damage or tear the latex free material.No anomalies were observed on any of the returned mating devices.All were also determined to be compatible with the 7 french balloon size of the td catheter.The probable cause cannot be determined at this time without additional sister samples.A device history review (dhr) lot#91-462-y1 and relevant commodities were reviewed and no non-conformances were found that would have contributed to the reported complaint.Additional information in section g1.

• 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: 8711428
• Report Number: 1713468-2019-00018
• Device Sequence Number: 11337567
• Product Code: DQE
• UDI-Device Identifier: 00840619043773
• UDI-Public: (01)00840619043773(17)190801(10)91-462-Y1
• 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): 05/22/2019

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: 91-462-Y1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER 80 CM 8.5 FR, MERIT MEDICAL MFR; INTRODUCER 80CM 8.5 FR, ARROW MFR; INTRODUCER 80 CM 8.5 FR, MERIT MEDICAL MFR; INTRODUCER 80CM 8.5 FR, ARROW MFR