MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CG+ PICC KIT: 3-L 6 FR X 50 CM W/VPS; INTRODUCER, CATHETER

Catalog Number CDC-45063-VPS2

Device Problems Material Rupture (1546); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problems Swelling (2091); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information requested.No additional information received at the time of this report.

Event Description

The customer reports the pt.Went for a power injected cat scan and the nurse checked the lumens that were infusing when the patient was on the table and they were working fine.She hooked up the power injector to the ct compatible lumen.The nurse states that the tech started the injector and stated that it was equalizing.The nurse states that the patients arm blew up with air.This patient is morbidly obese, and her arms are noted to be quite large.They checked her arm to see if any of the contrast had infiltrated, and no contrast was noted in the patient.They then noticed that the end of the picc line was slit open.They immediately removed the catheter and noted that right past the hub there was a slit in the catheter measuring almost 1 cm long.One edge of the slit is slightly irregular and has the rippled look.It is noted that the device looked bent and when the injector started there was significant pressure to cause the picc line to burst open.It's reported that the patient did not sustain harm.

Event Description

The customer reports the pt.Went for a power injected cat scan and the nurse checked the lumens that were infusing when the patient was on the table and they were working fine.She hooked up the power injector to the ct compatible lumen.The nurse states that the tech started the injector and stated that it was equalizing.The nurse states that the patients arm blew up with air.This patient is morbidly obese, and her arms are noted to be quite large.They checked her arm to see if any of the contrast had infiltrated, and no contrast was noted in the patient.They then noticed that the end of the picc line was slit open.They immediately removed the catheter and noted that right past the hub there was a slit in the catheter measuring almost 1 cm long.One edge of the slit is slightly irregular and has the rippled look.It is noted that the device looked bent and when the injector started there was significant pressure to cause the picc line to burst open.It's reported that the patient did not sustain harm.

Manufacturer Narrative

Qn#(b)(4).The customer returned a used 3-lumen picc catheter for evaluation.Visual and microscopic examination of the catheter revealed a vertical slit in the catheter body just below the juncture hub.The catheter body material around the slit appeared stretched, waved, and thin when compared to the rest of the catheter body.The appearance is consistent with a rupture caused from excessive pressure.The catheter was also slightly bent at the area of the slit.The slit in the catheter body was located approximately 0-9 mm from the distal end of the juncture hub.The catheter body outer diameter (od) measured.08335", which is within the specifications of.078"-.088" per catheter graphic.The catheter body length measured 20.00" which is within the specification of 19.6875"-20.1575" per catheter graphic.All three extension lines were flushed with water using a 10ml lab inventory syringe to functionally test the lumens.The proximal and medial extension lines functioned as expected when flushed and no leaks were observed on the catheter body.The catheter body leaked from the slit found during visual examination when the distal lumen was flushed.A lab inventory guide wire was advanced from the catheter distal tip to the rupture hole to confirm there were no blockages in the distal extension lumen between the tip and the location of the hole.A device history was performed on the catheter and no relevant manufacturing issues were identified.The customer stated that a bend was found at the location of the catheter hole.That bend was confirmed during visual inspection.Bends such as the one examined can disrupt the patency of the catheter and increase the pressure applied to the lumen, causing the lumen to burst.The current instructions-for-use (ifu) provided with this product notes that the maximum pressure of pressure injector equipment used with the pressure injectable picc may not exceed 300 psi.The maximum pressure injection flow rate for the distal lumen of this catheter is 6 ml/sec.The ifu also cautions the user to "ensure patency of intended pressure injectable lumen of catheter prior to pressure injection to reduce the risk of catheter failure" and provides the user with specific instructions for maintaining catheter patency.The ifu also states to continuously monitor indwelling catheters for the following: desired flow rate, security of dressing, adherence of stabilization device to skin and connection to catheter, correct catheter position.Use centim eter markings to identify if catheter position has changed.The customer report of the catheter body rupturing in use was confirmed through visual inspection of the returned sample.Visual inspection identified a rupture hole in the catheter body, adjacent to the juncture hub.The appearance of the damage was consistent with damage resulting from over pressurization of the catheter during use.The customer stated that a bend was found at the location of the catheter hole.That bend was confirmed during visual inspection.Bends such as the one examined can disrupt the patency of the catheter and increase the pressure applied to the lumen, causing the lumen to burst.The current instructions-for-use (ifu) provided with this product notes that the maximum pressure of pressure injector equipment used with the pressure injectable picc may not exceed 300 psi.The maximum pressure injection flow rate for the distal lumen of this catheter is 6 ml/sec.The ifu also cautions the user to "ensure patency of intended pressure injectable lumen of catheter prior to pressure injection to reduce the risk of catheter failure" and provides the user with specific instructions for maintaining catheter patency.The ifu also states to continuously monitor indwelling catheters for the following: desired flow rate, security of dressing, adherence of stabilization device to skin and connection to catheter, correct catheter position.Use centimeter markings to identify if catheter position has changed.A device history record review was performed with no relevant findings.Based on the condition of the returned sample and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI CG+ PICC KIT: 3-L 6 FR X 50 CM W/VPS
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8141853
• MDR Text Key: 129606180
• Report Number: 1036844-2018-00304
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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 Expiration Date: 08/31/2019
• Device Catalogue Number: CDC-45063-VPS2
• Device Lot Number: 23F18G0169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1