MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI; CATHETER,INTRAVASCULAR,THERAP

Catalog Number PR-35052-HPHNM

Device Problem Torn Material (3024)

Patient Problems Extravasation (1842); Pain (1994)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: picc in situ since (b)(6).The patient went for a scan on (b)(6) and said she heard what sounded like a 'ping' in her picc arm when the picc was injected.They flushed and removed the syringe.Patient then came to clinic on (b)(6) and they bled the picc during dressing and she complained it hurt.They stopped and flushed and she felt pain.Her arm then got red and she described the same 'ping' sound from few weeks back.They called imaging to do the test and it indicated extravasation at the slit.Picc removed and replaced with port a cath.

Event Description

It was reported that: picc in situ since 12/17.The patient went for a scan on 4/6 and said she heard what sounded like a 'ping' in her picc arm when the picc was injected.They flushed and removed the syringe.Patient then came to clinic on 13/6 and they bled the picc during dressing and she complained it hurt.They stopped and flushed and she felt pain.Her arm then got red and she described the same 'ping' sound from few weeks back.They called imaging to do the test and it indicated extravasation at the slit.Picc removed and replaced with port a cath.

Manufacturer Narrative

(b)(4).The customer returned a 2-lumen picc catheter for evaluation.The box clamp was attached to the center of the catheter body and an injection port was attached to the distal extension line.No other components were returned.Visual examination of the catheter with the naked eye revealed a hole in the center of the catheter body between the distal tip and box clamp.The catheter body was kinked/deformed at the location of the hole.Microscopic examination confirmed the hole in the catheter body and dried blood was observed within the catheter lumen.The hole was vertical along the length of the body and the edges were slightly jagged and opened apart.The appearance of the damage was consistent with a rupture due to over pressurization of the catheter.Residual adhesive material was observed on the catheter juncture hub indicating the catheter had been used.The hole in the catheter body was 0.25" in length and was located between 6.75"-7.00" from the juncture hub.The catheter body outer diameter adjacent to the hole measured 0.0696" which is within specification.The length of the catheter body was also found to be within specification.Both of the extension lines were flushed with water using a 10ml lab inventory syringe to functionally test the lumens.The proximal extension line functioned as expected when flushed.No leaks were observed on the catheter body which indicates the hole is contained to the distal lumen.The distal extension line was found to be blocked which is likely due to the dried blood observed in the visual inspection.A lab inventory 0.009" 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.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 ranges from 4 ml/sec to 6 ml/sec.Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection." 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.A pressure injectable picc injection log is also provided with this product which specifies maximum indicated pressure injection flowrates for all catheter sizes and lumens.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 center of the catheter body.The appearance of the damage was consistent with damage resulting from over pressurization of the catheter during use.The instructions-for-use and product labeling supplied with this product provide detailed information on catheter pressure injection limitations.Based on the condition of the returned sample and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7663728
• MDR Text Key: 113188394
• Report Number: 3003737899-2018-00079
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1