MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CS-15703-E

Device Problems Complete Blockage (1094); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that when advancing the catheter guide it is bent and generates occlusion.

Manufacturer Narrative

Qn#(b)(4).The customer returned a cvc kit lidstock with one catheter, introducer needle, and box clamp assembly.Visual inspection of the spring wire guide (swg) could not be performed as the guide wire was not returned for analysis.Visual inspection of the catheter revealed no obvious defects.The length of the catheter body returned was 218 mm with is within the specifications of 207-227 mm from product drawing.A lab inventory swg was advanced through the returned catheter with no resistance.Additional testing could not be performed on the swg as no sample was returned for analysis.The catheter was flushed with water to confirm no blockage.Water passes through all extension lines except the proximal (white).A device history record review was performed on the swg and catheter and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply undue force on guidewire to reduce risk of possible breakage." complaint testing could not be performed on the swg as the component was not returned for analysis.The returned catheter met all relevant dimensional and functional testing.A device history record review was performed on both the swg and catheter and no relevant findings were identified.Without the swg 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.

Event Description

The customer reports that when advancing the catheter guide it is bent and generates occlusion.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9329982
• MDR Text Key: 177786557
• Report Number: 9680794-2019-00454
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: CS-15703-E
• Device Lot Number: 14F19A0196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.
• Patient Age: 91 YR