MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 5 FR 60CM; CATHETER, FLOW DIRECTED

Model Number	IPN000069
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that staff was unable to advance the wire through the end.As a result, a new catheter was used.No information was able to be obtained regarding the patient.
Additional Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "unable to advance wire through the end" is confirmed.During the investigation, the distal opening of the injection lumen was found blocked by epoxy.During functional testing, the guidewire was unable to be advance through the distal tip of the catheter due to the blocked distal opening.The root cause is manufacturing related.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 non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported that staff was unable to advance the wire through the end.As a result, a new catheter was used.No information was able to be obtained regarding the patient.

• Brand Name: CATH PKGD: WEDGE 5 FR 60CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10784774
• Report Number: 3010532612-2020-00327
• Device Sequence Number: 19670289
• Product Code: DYG
• UDI-Device Identifier: 00801902002846
• UDI-Public: 00801902002846
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 02/28/2021
• Device Model Number: IPN000069
• Device Catalogue Number: AI-07123
• Device Lot Number: 16F19K0076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1