MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; WIRE GUIDE CATHETER

Catalog Number RA-04020

Device Problems Device Damaged Prior to Use (2284); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports a small tear/shear at the distal tip of the catheter.The alleged defect was detected when the package was opened and inspected pre-procedure.

Manufacturer Narrative

(b)(4).The customer returned one opened radial arterial catheterization set for evaluation.The returned device contained a slightly bent needle; however, because this was not reported by the customer, it is assumed that the needle was bent during return shipping.Visual examination of the returned catheter revealed a small portion of excess material at the tip.The returned guide wire was able to fully advance through the needle and catheter with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "do not reinsert needle into catheter to minimize risk of catheter damage." the reported complaint of a defective catheter tip was confirmed by complaint investigation.The returned catheter contained a small excess of material at the tip.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample received, it was determined that manufacturing caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.

Event Description

The customer reports a small tear/shear at the distal tip of the catheter.The alleged defect was detected when the package was opened and inspected pre-procedure.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• Type of Device: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7582448
• MDR Text Key: 110575840
• Report Number: 9680794-2018-00133
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F18A0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1