MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-42703-P1A

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Customer returned one used spring-wire guide (swg) with the swg assembly. A visual inspection of the swg revealed one kink and a bend in the swg body. Microscopic examination of the guide wire confirmed the kink and bend. There are offset coils at the kink. Both welds were present and were observed to be full and spherical. The kink and bend in the swg were located approximately 2. 0 and 3. 4 cm from the distal end of the swg, respectively. The swg length and outer diameter were measured and were found to be within specification. A manual tug test confirmed that both welds remain intact. The lot number was not reported; however, a device history record (dhr) review was performed based on a lot number from the sales history data of the customer. No relevant findings were identified. The instructions-for-use (ifu) provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use. The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire. The reported complaint that the swg was kinked was confirmed based on visual inspections of the returned sample. A kink and a bend were both found in the swg body. The returned guide wire met all relevant dimensional requirements and a dhr review did not identify any manufacturing related issues. Based on the condition of the guide wire 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.

Event Description

The customer alleges that the guide wire kinked during use.

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the guide wire kinked during use.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6910765
• MDR Text Key: 247685900
• Report Number: 1036844-2017-00356
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CDC-42703-P1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial