MAUDE Adverse Event Report: ICU MEDICAL, INC. 8F OPTIQ SVO2/CCO CATHETER

Model Number 52510-12

Device Problem Component(s), broken (1103)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

Int'l ((b)(6)) complaint received reporting "balloon broken" on one 52510-12 8fr optiq catheter.It was reported this occurred during pre-insertion testing where there was no pt involvement.Device return: one used 52510-12 8f catheter attached/to st-09880 contamination shield was returned for investigation.The "as-received" catheter showed residual blood was present on the returned devices.Visual inspection and analysis (pre and post decontamination) of the 52510-12 8f catheter recorded the catheter balloon was damaged/torn.Based on the visual inspection, the reported "broken balloon" issue was confirmed.Lot build review: a review of the mfr lot build database for the reported lot# 30-600-jw (mfg date 06/01/2013) shows 300 units were mfg, tested, inspected and released.There was no exception documents generated during the lot build.Add'l investigation: search/review of the #st-09880 contamination shield documented this device model is intended for use on 7/7.5 f catheters.

Manufacturer Narrative

The catheter direction for use (dfu) provides specific instructions/tabled info that identify required sized accessory devices.As labeled this 8f catheter requires ancillary devices (introducers/contamination shield) size of 8.5f or larger.Additionally the dfu instructs the user the "retest the balloon for proper function after insertion through the shield" prior to pt use.Findings: based on the "as-received" condition of the returned 52510-12 8f catheter the reported "broken balloon" issue was verified.The root cause of the damages to the balloon component is a result of contraindicated use of an incorrect size contamination shield.The investigation report, photographs and the directions for use (dfu) will be provided to the distributor/facility for their review and staff training.

• Brand Name: 8F OPTIQ SVO2/CCO CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton dr; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 4436008
• MDR Text Key: 5387873
• Report Number: 2025816-2014-00210
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52510-12
• Device Catalogue Number: 52510-12
• Device Lot Number: 30-600-JW
• Other Device ID Number: PR# 27408
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ARROW #ST-09880 CONTAMINATION SHIELD