MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ACCESS TRAY; WIRE GUIDE CATHETER

Catalog Number	AA-15611-S
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the sheath was inserted into the radial artery and blood was squirting profusely from the rubber in the hub as soon as the introducer and wire was removed.The hemostatic valve did not contain the blood.They had to use a new set".There was no patient death.Patient current condition reported as fine.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of sheath valve leak in use is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported "the sheath was inserted into the radial artery and blood was squirting profusely from the rubber in the hub as soon as the introducer and wire was removed.The hemostatic valve did not contain the blood.They had to use a new set." there was no patient death.Patient current condition reported as fine.

• Brand Name: ACCESS TRAY
• Common Device Name: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8127208
• Report Number: 3010532612-2018-00356
• Device Sequence Number: 11195579
• Product Code: DQX
• UDI-Device Identifier: 00801902002426
• UDI-Public: 00801902002426
• Combination Product (Y/N): N
• Initial Reporter Country: WA
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2020
• Device Catalogue Number: AA-15611-S
• Device Lot Number: 71F18F1080
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 90