MAUDE Adverse Event Report: COOK INC BEACON TIP AUROUS CENTIMETER VESSEL SIZING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

On (b)(6) 2015 at 11:42, during a angiography of the pelvic artery: per standard procedure, a contrast injection using a pump was carried out (12ml/s, volume 20ml, psi1000).During injection, a bang sound was audible and contrast medium splashed from the extra corporal end of the measuring pigtail catheter.The stream was directed straight at the physician's face.A hole measuring 3x3 mm was found 4cm from the proximal end.Despite his lead crystal protective glasses, the doctor's eye was contaminated with contrast medium.The eye was rinsed immediately using nacl 0.9%.According to the initial reporter, the user did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation: a review of the complaint history, device history record, instructions for use (ifu), quality control (qc) and pressure injection testing of 2 returned devices was conducted for the purpose of this investigation.The actual device was not returned to assist with the investigation.However, 2 returned devices of the same lot were subjective to pressure injection testing, results as follows: catheter #1 was injected with pressure set to specified packaging/ifu settings and it did not burst.Catheter #2 was set above user specified packaging/ifu settings, which resulted in burst/rupture just distal of the strain relief in the catheter shaft.Final inspection for angiographic catheters inspects material, proximal fittings and integrity of lumens.As the actual device was not returned, it is not possible to determine the exact root cause of the event.However, based on the information provided and the testing of 2 devices from the same lot, it is likely that the device received excessive pressure that resulted in the catheter being exposed to forces beyond its design.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.The addition of this complaint does not change the conclusion that no further risk reduction is required.

Event Description

On (b)(6) 2015 at 11:42, during a angiography of the pelvic artery: per standard procedure, a contrast injection using a pump was carried out (12ml/s, volume 20ml, (b)(4)).During injection, a bang sound was audible and contrast medium splashed from the extra corporal end of the measuring pigtail catheter.The stream was directed straight at the physician's face.A hole measuring 3x3 mm was found 4cm from the proximal end.Despite his lead crystal protective glasses, the doctoreye was contaminated with contrast medium.The eye was rinsed immediately using nacl 0.9%.According to the initial reporter, the user did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: BEACON TIP AUROUS CENTIMETER VESSEL SIZING CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5113180
• MDR Text Key: 27102350
• Report Number: 1820334-2015-00591
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NR5.0-35-100-P-10S-PIG-CSC-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR