MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number AK-45703-CDC

Device Problem Unraveled Material (1664)

Patient Problems Pneumothorax (2012); No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are incomplete at the time of this report.

Event Description

The customer alleges that the wire unraveled becoming too weak to thread the sheath and causing a sharp end that bent sideways during removal.No patient injury or consequence reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The device history records (dhr) for the guide wire were reviewed with no evidence to suggest a manufacturing related cause.The potential cause of guide wire unraveling could not be determined based upon the information provided and without a sample.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the wire unraveled becoming too weak to thread the sheath and causing a sharp end that bent sideways during removal.No patient injury or consequence reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one guide wire for evaluation.A visual exam was performed and it was observed that the guide wire had five kinks and was unraveled from the distal end.The distal weld was present at the end of the coil wire.Microscopic examination revealed that both welds were full and spherical and that the proximal weld appears intact.Microscopic examination also revealed discoloration and necking of the core wire in the area of the break.Discoloration at the broken end of the core wire was consistent with proximity to a weld.The broken core wire measured 600mm, which meets the length specification.The diameter was also found to be within specification.A manual tug test confirmed that the distal weld remains intact.A device history record (dhr) review was performed on the guide wire , introducer needle , and ars with no relevant findings.The instructions for use (ifu) for this product, describes suggested techniques to minimize the likelihood of guide wire damage during use.(con't) other remarks: the reported complaint of the guide wire unraveled was confirmed through visual inspection of the returned sample.The guide wire exhibited signs of use and was unraveled from the distal weld.No manufacturing defects were found during this investigation.Arrow guide wires of this size (0.32") are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:1999 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of the guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, it was determined that operational context caused or contributed to the event.

Event Description

The customer alleges that the wire unraveled becoming too weak to thread the sheath and causing a sharp end that bent sideways during removal.No patient injury or consequence reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Type of event corrected to 'serious injury'.Additional information received via review of the maude database (report #(b)(4)).It was reported that the patient suffered a pneumothorax.This required insertion of a chest tube and prolonged hospitalization to recover.The customer was contacted over the phone and verified that this information was correct.The customer also stated this information was unknown to her at the time the complaint was submitted to the sales rep.Other remarks:.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 6270523
• MDR Text Key: 65520652
• Report Number: 3003737899-2017-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/17/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: AK-45703-CDC
• Device Lot Number: 13F16M0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 01/23/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/08/2017; 04/07/2017; 05/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• 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): Hospitalization; Required Intervention