MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-45703-P1A

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the wire kinked during insertion.A delay in the procedure was reported.No patient injury or harm.

Manufacturer Narrative

Qn#: (b)(4).The customer returned one guide wire and lid stock for evaluation.Visual examination confirmed the guide wire contained four curves.The coils appeared slightly closer; however, they were not offset or unraveled.The returned guide wire had slight bends 221, 260, 310, and 363 mm from the proximal end.The length and outer diameter of the returned wire were measured and were found to be within specification.The returned guide wire was able to pass through a lab inventory catheter with moderate resistance.A manual tug test confirmed that both the proximal and distal welds are fully intact.A device history record (dhr) review was performed with no relevant findings to suggest a manufacturing related issue.The instructions for use (ifu) provided with this kit warns the user, "do not cut spring-wire guide to alter length.Do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." (con't) other remarks: the reported complaint of the guide wire kinking during use was confirmed by complaint investigation.The returned guide wire contained four slight bends.The coils appeared slightly closer; however, they were not offset or unraveled.A dhr review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample as received and the report that the incident happened during use, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that the wire kinked during insertion.A delay in the procedure was reported.No patient injury or harm.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
• 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: 6950904
• MDR Text Key: 90201178
• Report Number: 1036844-2017-00377
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 23F17G0262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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