MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14402

Device Problem Complete Blockage (1094)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: "during the passage of the bilumen catheter in patient.The distal lumen of the occluded catheter is sealed, catheter and defective guide".

Event Description

The customer reports: "during the passage of the bilumen catheter in patient.The distal lumen of the occluded catheter is sealed, catheter and defective guide".

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.

Event Description

The customer reports: "during the passage of the bilumen catheter in patient.The distal lumen of the occluded catheter is sealed, catheter and defective guide".

Manufacturer Narrative

(b)(4).The customer returned one swg, one catheter, and one lidstock for analysis.No definite signs-of-use were observed.Visual analysis revealed that the guide wire was inserted through the catheter.The catheter body appeared to have one slight bend towards the distal end.The guide wire was removed from the catheter with little to no difficulty.No damage was observed on the guide wire; however, the kink/bend on the catheter was still visible.No other defects or anomalies were observed.The catheter body total length from the juncture hub to the distal tip measured 5 1/16", which is within the specification limits of 4 13/16"-5 3/16" per the catheter graphic.The catheter outer diameter measured.056", which is within the specification limits of.054"-.058" per the catheter extrusion graphic.The inner diameter at the catheter tip measured.021", which is within the specification limits of.021"-.023" per the catheter graphic.The distal extension line from the juncture hub to the luer hub measured 3 7/16", which is within the specification limits of 3"-3 1/2" per the catheter graphic.The distal extension line outer diameter measured.084", which is within the specification limits of.084"-.088" per the distal extension line extrusion graphic.The distal extension line inner diameter measured.058", which is within the specification limits of.055"-.059" per the distal extension line extrusion graphic.The guide wire was passed through the distal end of the returned catheter.Significant resistance was observed at the kinking on the catheter; however, the guide wire was able to pass completely through the catheter.The distal and proximal lumens were flushed with water using a lab inventory syringe.No blockages were observed.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report of an extension line blocked in use could not be confirmed by complaint investigation of the returned sample.The extension lines passed all relevant visual and functional inspection.A separate issue was identified that resulted in a non-conformance; however, this issue did not cause or contribute to a lumen blockage.A device history record review was performed with no relevant findings.Based on the customer report and the sample received, no problem was found with the extension line on the returned catheter.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8817656
• MDR Text Key: 151927082
• Report Number: 9680794-2019-00261
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2019

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
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: CS-14402
• Device Lot Number: 14F18H0231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 08/12/2019; 10/07/2020
• Supplement Dates FDA Received: 08/16/2019; 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1