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 Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problems Extravasation (1842); No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the picc split during use.A contrast was used and did extravasate below the skin surface, but most of it leaked out and there were no patient complications.A new picc was inserted.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 2-l 5fr x 50cm picc catheter for evaluation.Visual and microscopic examination of the catheter revealed a hole in the catheter body.The hole was longitudinal along the catheter body and the catheter body material around the hole appeared stretched and thin when compared to the rest of the catheter body.The appearance is consistent with a rupture from excessive pressure.The luer hub on each extension line states the max pressure is 5 ml/sec.The hole in the catheter is located approximately 14.2-14.6 cm (4 mm in length) from the distal end of the juncture hub.The length and outer diameter of the catheter body were measured and were found to be within specification.With the catheter distal tip occluded, water was injected into the catheter luer hubs for both extension lines using a lab inventory 10 ml syringe.Significant leakage was observed from the catheter body when the proximal extension line was pressurized.The location of the leak was consistent with the hole identified during visual inspection.No leak was observed from the distal line.A lot number was not provided by the customer; therefore, the customer's sales history was used to obtain a lot number and perform a device history record review for the investigation.The device history record review was performed and no manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit contains several warnings in regards to pressure injection which includes ensuring patency of intended pressure injectable lumen of catheter prior to pressure injection to reduce the risk of catheter failure and/or patient complications.The ifu also warns not to use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi), to reduce the risk of intraluminal leakage or catheter rupture.The ifu warns not to exceed ten (10) injections or the maximum pressure of 300 psi on power injector equipment to reduce the risk of catheter failure and/or tip displacement.The ifu instructs the user to apply warm contrast to the body temperature prior to power injection and that pressure limit settings may not prevent over pressurization of an occluded catheter.The volume priming document supplied with this kit specifies the volumetric flow rates the catheter can withstand.This catheter's max flowrate is 5 ml/sec.The customer did not provide the flow rate used during the procedure.The customer reported issue of the catheter body rupturing during use was confirmed during the sample investigation.Visual and microscopic examination of the catheter revealed a hole in the catheter body.The hole was longitudinal along the catheter body and the catheter body material around the hole appeared stretched and thin when compared to the rest of the catheter body.The appearance is consistent with a rupture from excessive pressure.Functional testing was able to confirm the rupture was in the proximal lumen.A device history record review was performed and no relevant findings were identified.Based on the condition of the returned sample, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports the picc split during use.A contrast was used and did extravasate below the skin surface, but most of it leaked out and there were no patient complications.A new picc was inserted.

• 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
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7472335
• MDR Text Key: 106874916
• Report Number: 3003737899-2018-00040
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 13F17F0586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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: 63 YR