MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Catalog Number CL-07745

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The customer reports the metal ring of the sheath tip got damaged/burred during insertion.

Event Description

The customoer reports the metal ring of the sheath tip got damaged/burred during insertion.

Manufacturer Narrative

(b)(4).The customer returned one sheath ext assembly with dilator.Visual examination showed signs of use in the form of biological material near the sheath tip.Microscopic examination revealed damage on the sheath tip.The metal ring on the sheath tip was damaged and did not wrap around the entire circumference of the sheath tip.The dilator tip was also damaged.No other defects or anomalies were observed.The length and outer diameter of the sheath were measured and were found to be within specification.A device history record review was performed with no relevant findings.The ifu provided with the kit informs the user to "perform skin wheal using desired needle." the ifu also cautions the user, "do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage." the customer report that the sheath tip was damaged was confirmed through complaint investigation.Signs of use in the form of biological material were identified near the distal tip of the sheath.The returned sample met all dimensional requirements, and a device history record review showed no relevant findings.Based on the returned sample, the probable cause of the damage is unintentional user error.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8116162
• MDR Text Key: 128873236
• Report Number: 9680794-2018-00257
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: CL-07745
• Device Lot Number: 14F17L0442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1