MAUDE Adverse Event Report: ICU MEDICAL, INC. TD TORQUE LINE HEPARIN COATED CATHETERS

Model Number 41239-06; 41237-06

Device Problem Inflation Problem (1310)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

Initial analysis: the involved catheter lot# are unknown.A review of the mfg.Lot build database for the "potential" lot numbers was performed.The results recorded 41237-06 lot# 76-598-sj (mfg.05/2017) showed (b)(4) units; 77-248-y1 (mfg.05/2017) showed (b)(4) units and 41239-06 lot# 80-702-jw (mfg.08/2017) showed (b)(4) units were all mfg., tested including 100% inflation testing, inspected and released.There were no exception documents generated during the lot builds.The involved catheter devices were not returned.One (1) packaged 41239-06 7f td torque-line catheter, lot# 80-702-jw and one (1) packaged 41237-06 8f td torque-line catheter, lot# 76-598-sj.Were returned for investigation.Qe investigation: dimensional analysis of the two returned unused catheters recorded no out of spec conditions.Functional performance testing including inflation cycle testing was performed per the applicable specifications.The results recorded each of the catheters balloons successfully met the 100 cycle inflation testing.There were no functional and or performance issues replicated.Findings: engineering testing and analysis of the returned (unused) catheters recorded no performance and or out of spec conditions.

Event Description

Complaint received reporting balloon inflation failures with use of td catheters.The initial information received reports at an unspecified time after insertion the catheter balloon(s) failed to maintain inflation.The devices were removed and replaced with no further issues encountered.Follow up information reports the issues/events occurred with 41239-06 td torque-line catheter, 7f, 4 lumen, 110 cm, heparin coated, lf and 41237-06 td torque-line catheter, 8f, 5 lumen, 110 cm, ra/ra, heparin coated lf.There were no reported adverse patient consequences.

• Brand Name: TD TORQUE LINE HEPARIN COATED CATHETERS
• Type of Device: TD TORQUE LINE HEPARIN COATED CATHETERS
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton drive; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 7135282
• MDR Text Key: 96053680
• Report Number: 2025816-2017-00227
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/18/2017

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 Model Number: 41239-06; 41237-06
• Device Catalogue Number: 41239-06; 41237-06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1