MAUDE Adverse Event Report: ICU MEDICAL, INC. 8F TD TORQUE LINE HEPARIN COATED CATHETERS

Model Number 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 10/10/2017

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 number 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 were all mfg., tested including 100% inflation testing, inspected and released.There were no exception documents generated during the lot builds.Device return: one (1) used 41237-06 8f td torque-line catheter w/ used arrow cath-gard st-09875 ( 7.5 - 8f) contamination shield; one packaged 41237-06 8f td torque-line catheter, lot# 77-248-y1.Qe analysis: visual analysis of the "as-received" used catheter recorded the balloon was damaged/torn, but intact.Based on the visual analysis the reported product issue (inflation failure) was confirmed.No additional testing was performed.Dimensional analysis of the unused 41237-06 catheter device recorded no out of spec.Conditions.Functional performance testing, including inflation cycle testing was performed per the applicable specifications.The results recorded the unused 41237-06 catheter balloon successfully met the 100 cycle inflation testing.There were no functional and or performance issues replicated.Additional notes: the 41237-06 8f catheter direction for use (dfu) provides specific recommendations and instructions concerning pre-testing and use of accessory devices.The dfu identifies the 41237-06 8f td catheters requires size 8.5 f or larger ancillary devices (introducers/contamination shield).Additionally the dfu instructions also advise to retest the balloon for proper function after insertion through the shield.Findings: visual analysis of the "as-received" used 41237-06 8f td catheter confirmed the reported product issue.Testing and analysis of the unused 41237-06 8f td catheter recorded no performance and or out of spec conditions.

Event Description

Complaint received reporting balloon inflation failure with one (1) 41237-06 td torque-line catheter, 8f, 5 lumen, 110 cm, ra/ra, heparin coated, lf.The initial information received reports at an unspecified time after insertion the catheter balloon failed to maintain inflation.The device was removed and replaced with no further issues encountered.There were no reported adverse patient consequences.

• Brand Name: 8F TD TORQUE LINE HEPARIN COATED CATHETERS
• Type of Device: 8F 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: 7136233
• MDR Text Key: 96036899
• Report Number: 2025816-2017-00228
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00840619043759
• UDI-Public: 00840619043759
• 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

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41237-06
• Device Catalogue Number: 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
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1