MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. TRANSRADIAL ACCESS TRAY; INTRODUCER, CATHETER

Catalog Number	AA-10611-1
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the dilated tube was inserted into the patient's radial artery, however, the catheter could not pass through the sheath and had to be removed."the guide catheter could not be advanced through the sheath." there was no report of patient complications.
Event or Problem Description
It was reported that the dilated tube was inserted into the patient's radial artery, however, the catheter could not pass through the sheath and had to be removed."the guide catheter could not be advanced through the sheath." there was no report of patient complications.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of catheter tight in sheath is confirmed.The catheter was not returned, but the returned transradial sheath extrusion was inspected dimensionally, and it was noted as out of specification, which could result in difficulty of catheter insertion.The root cause of the complaint is undetermined.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.A nonconformance has been initiated to further investigate the root cause.

• Brand Name: TRANSRADIAL ACCESS TRAY
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7842191
• Report Number: 3010532612-2018-00282
• Device Sequence Number: 11379828
• Product Code: DYB
• UDI-Device Identifier: 00801902066633
• UDI-Public: 00801902066633
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K112554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: 10/31/2019
• Device Catalogue Number: AA-10611-1
• Device Lot Number: 14F17L0348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1