MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VASACULAR UNKNOWN; CATHETER, PERCUTANEOUS

Catalog Number VASCULAR UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 09/10/2019

Event Type  Death  

Manufacturer Narrative

Qn# (b)(4).Additional information requested of the user facility by teleflex regarding this event.The customer responds and indicates that they are unable to answer our questions regarding this event.The customer reports that the device is available for onsite inspection.Note: the medwatch from the user facility did not have a uf/importer report#.

Event Description

According to the medwatch from the user facility "the pa catheter was discontinued from the two-lumen central venous access catheter.Two hours later, the patient coded, and bleeding was noted exiting the introducer".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

According to the medwatch from the user facility "the pa catheter was discontinued from the two-lumen central venous access catheter.Two hours later, the patient coded, and bleeding was noted exiting the introducer".

• Brand Name: ARROW VASACULAR UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9266346
• MDR Text Key: 164620158
• Report Number: 9680794-2019-00402
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR