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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
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:.
 
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Brand NameARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER, 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 Key6270523
MDR Text Key65520652
Report Number3003737899-2017-00004
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
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
Date FDA Received01/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberAK-45703-CDC
Device Lot Number13F16M0015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/23/2017 Patient Sequence Number: 1
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