MAUDE Adverse Event Report: ICU MEDICAL, INC. TD CATHETER,7F,4 LUMEN,110 CM, HEPARIN COATED

Model Number 41229-02

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

Review of lot number 52-219-sj showed that 61 each were manufactured, tested, inspected and released in may of 2015 with no anomalies reported.

Event Description

Complaint received stating " thermodilution catheter balloon ruptured while being inflated in patient.Unable to ascertain if pieces of balloon remained in patient.Staff reported the balloon tested without difficulty before insertion." no serious patient consequences reported.

Manufacturer Narrative

Visual analysis: 08/06/2015 - received one used 41229-02, td catheter, 7f, 4 lumen, 110 cm, heparin coated, lf; lot number 52-291-sj (manufactured may 2015).No other devices were returned.The balloon rupture is confirmed.The supplied 3ml syringe was attached to the inflation line.The inflation line was occluded and could not be flushed.Investigation summary: the balloon was visually examined and no portions of the balloon were observed to be missing.The reported complaint of ruptured balloon was confirmed.The root cause of the failure could not be determined the failure observed has been seen previously from stress cracking.We have only been able to recreate the observed failure from over inflation of the balloon.

• Brand Name: TD CATHETER,7F,4 LUMEN,110 CM, HEPARIN COATED
• Type of Device: TD CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 4996476
• MDR Text Key: 25005865
• Report Number: 2025816-2015-00086
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 07/21/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: 41229-02
• Device Catalogue Number: 41229-02
• Device Lot Number: 52-291-SJ
• Other Device ID Number: PR#31091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Type of Device Usage: N
• Patient Sequence Number: 1