MAUDE Adverse Event Report: ICU MEDICAL, INC. TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number	412290402
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return for evaluation.It has not been received.
Event or Problem Description
User facility voluntary medwatch report mw5085197 was received that stated the following: ¿right heart catheter inserted, when catheter was in pulmonary wedge position, user was unable to pull blood from inner lumen.Catheter was removed and noted to have ruptured balloon tip¿.It was additionally indicated that there was no adverse event, but there was a serious injury that required intervention.No additional information has been provided.
Additional Manufacturer Narrative
Initially it was reported that the device would be returned.No product samples were returned for investigation.Additionally, no pictures or videos were provided by the customer documenting the reported issue.Therefore, a comprehensive investigation cannot be conducted and a root cause cannot be evaluated.The manufacturing and design records were reviewed and no non-conformances or anomalies were found that would have contributed to the reported issue.The dhr for lot 90-997-sj was reviewed and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: TD 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: 8596114
• Report Number: 1713468-2019-00014
• Device Sequence Number: 2074539
• Product Code: DQE
• UDI-Device Identifier: 00840619043650
• UDI-Public: (01)00840619043650(17)190701(10)90-997-SJ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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: 07/01/2019
• Device Catalogue Number: 412290402
• Device Lot Number: 90-997-SJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1