MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC FIRST PICC 26G; PICC (PERIPHERALY INSERTED CENTRAL CATHETERS)

Catalog Number 384232

Device Problem Positioning Problem (3009)

Patient Problems Death (1802); Dyspnea (1816); Pericardial Effusion (3271)

Event Date 10/01/2015

Event Type  Death  

Manufacturer Narrative

The following is the manufacturer's preliminary analysis: as the actual sample is currently under evaluation at argon singapore, the preliminary investigation as of date is limited to the internal manufacturing process and batch documentation review and commentary by (b)(4) clinical expert and comments by the hospital pharmacist.A review of the batch documentation, which includes device history records and inspection reports, showed that no problem was found relating to visual and functional inspection of the affected first picc catheter sub-assembly lot number during the manufacturing process.Based on the review of the records it is confirmed that the production operations, materials and testing were properly performed on the devices.The test results showed no failures or indication of a potential problem related to the reported failure of the first picc product.There is no abnormally found on the raw material records per certificate of conformance and part was released according to specification.All assembly operations were completed to specification.The first picc catheter assembly underwent 100% visual inspection,100% leak and flow verification and sampling burst test.All inspection records showed no non conformity.All machine parameters used in manufacturing first picc product and sub-assemblies were checked and all were within specification.The equipment calibration and preventive maintenance reports were also verified and confirmed within the equipment specification.Production operators who manufactured the sub-assemblies work order were all trained per relevant assembly procedures.At the end of the evaluation there was no non-conformance found on the inspection records, operation records, material records or testing.The hospital pharmacist has since stated that the patient's death was not directly linked to the picc, and the neonatal physician has stated that the picc was not correctly placed and that the x-ray was misread, and that the cause of death was due to an effusion around the heart.Argon's clinical specialist has stated that silicone does not grow or stretch in the body.You can stretch out a silicone catheter if you pull both ends of it, but this is virtually impossible to do in situ.If the picc supposedly ended up in the ventricle, one would challenge the accuracy of the first x-ray.Given the device was only pulled back 1.5 cm it is unlikely that it was really in the ventricle.Even in a very small micro-premature infant, the distance from the superior vena cava into the atrium into the ventricle would probably exceed 1.5 cms.The specialist also raised the question of error in x-ray/placement.It is not clear how many x-ray views were taken.Most hospitals routinely do two views to confirm tip location.Entry into the ventricle is extremely unlikely while entry into the right atrium could be possible if inserted too deeply.The specialist went on to say that is important when doing xrays to ensure that all x-rays be taken with the baby in the same position.This is typically in the swaddling position with the arms at about 45 degrees out from the body because this is the position that the baby lies in most of the time the location of the tip will vary based upon the position of the arms.If the arms are raised over the head, the tip will actually go deeper into the heart.The specialist has conjectured if this might have been part of the problem.Since the actual sample is currently under investigation and more formal documentation from the hospital is not yet available, the actual cause of the failure has not be determined.There are no similar reports of this nature.No additional corrective and preventive action can be established at the moment.Supplementary report will be provided when sample/data are received for investigation.Argon has reached out to the chief physician of the hospital's (b)(6) department for more information, and the hospital has agreed to allow (b)(4) representatives to come and visit the hospital.The hospital has offered the (b)(6) 2016 as a provisional date for the visit.

Event Description

On (b)(6) a catheter was inserted up to marking 13 cm (catheter cut at 16cm, 3 cm out of the arm).An x-ray was performed and the initial assessment was that everything was acceptable.On (b)(6) an x-ray was performed because the child was not breathing properly.The person reading the x-ray felt that the catheter had gone down into the ventricle based on the initial report by the sales rep.This is not possible as 3 cm was still exterior on the patient.The catheter was withdrawn 1.5 cm.This initial complaint was sent to (b)(4) on (b)(6) stating no patient injury had occurred.On (b)(6) (b)(4) distributor received a new report stating that the patient above had expired and the sales rep was initially told that the catheter had caused the patient's death.Further communication with the hospital pharmacist and the (b)(6) physician stated that the patient autopsy revealed cardiac injuries with the presence of pericardial effusion, and belief that the catheter was misplaced from the beginning, and original x-ray regarding placement had been misread, and that the picc was not the direct cause.

Manufacturer Narrative

Physical material review: one (1) used first picc 26g, 1.9f device was received.Visual examination was conducted on the used device observed that the single lumen silicon catheter tube was broken/cut at approx 16.5cm marking upon receipt.The smooth edges of the cut silicon tubing (with oval-egg shaped cross sectional appearance) indicating that the catheter was likely cut by some instrument.The elliptical cross-sectional profile appearance indicated that the catheter was crimped instead of broken due to pulling or material defects.Similarly the 1st sample received on 11/27/2015, the edges of the cut silicon tubing has smooth-circular shaped appearance indicating that the catheter was cut by a tool such as trim tool.The profile of the cut edge is similar to the reference sample that was deliberately cut using a trim tool.The 2nd returned sample device also had a non-argon green connector connected to the barbed adapter.The catheter had blood stained at approx between the 4cm and 5cm marking.Visual inspection on the returned device confirmed no other visual defects on the entire silicon tubing and the molded assembly.Device history record review: a review of the batch documentation, which includes device history records and inspection reports showed no nonconformance in the visual and function inspection of the affected first picc catheter during the mfg.Based on the review of these records, the production operations materials and testing were properly performed on the devices.The test results showed no failures or indication of a potential problem related to the first picc product.The raw material records were reviewed and all parts were released according to specs.(b)(4).

Manufacturer Narrative

In the previous reports, we informed about patient death (but not device related).This report correct the data that there is in fact no patient death and no serious injury.Hospital report the wrong patient.

Event Description

Additional information: on (b)(6) 2015 the catheter was trimmed at 16 cm length with argon guillotine and inserted in place at marking 13 cm (with catheter cut at 16 cm, 3 cm out of the arm) x-ray confirmed tip located at svc.On (b)(6) 2015 patient (infant) experienced respiratory issues and x-ray indicated catheter tip is now in base of ventricle.Catheter pulled back at 1.5 cm and 3rd x-ray confirmed position ok.The catheter did not migrate, the 3 cm of the catheter external to the vasculate was still showing 3 cm and the external fixation was intact, the infant had their arm extended for measurement, etc, thereby minimizing the risk of catheter extended in-situ due to the child raising their arms.In this case, the catheter "somehow" extended in-situ, thereby allowing the tip to end up in the right ventricular of the infant "(b)(6)." there is no malfunction of the device and did not cause death or serious injury.Considering that the patient infant, (b)(6), is only approx (b)(6), a small extension of catheter length if recurred could possibly cause serious injury.

• Brand Name: FIRST PICC 26G
• Type of Device: PICC (PERIPHERALY INSERTED CENTRAL CATHETERS)
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC
• Manufacturer Contact: 7509148
• MDR Report Key: 5301854
• MDR Text Key: 33617444
• Report Number: 8020616-2015-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 384232
• Device Lot Number: 411341
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2000
• 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 Outcome(s): Death; Other
• Patient Weight: 1