MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-25123-F

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the dilator is bent during insertion of the arrow dialysis catheter.

Event Description

The customer reports that the dilator is bent during insertion of the arrow dialysis catheter.

Manufacturer Narrative

(b)(4).Corrected data: brand name corrected to arrow cvc set: 3-lumen 12 fr x 20 cm.Common device name corrected to catheter, intravascular, therapeutic.Procode corrected to foz.The customer did not return a complaint sample; however, they supplied a photo showing a bent dilator along with other components.The dilator is bent towards the distal end of the dilator body and shows evidence of use but it cannot be determined without the sample to evaluate.A probable cause of the bent dilator cannot be determined from the photos and without the sample to evaluate.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit tells the user "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide." the report that the dilator was bent was confirmed through examination of the customer supplied photo.The image showed the dilator bent towards the distal end of the dilator body; however, the actual complaint sample was not returned for evaluation.The device history records for the dilator was reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the dilator damage could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the dilator is bent during insertion of the arrow dialysis catheter.

Manufacturer Narrative

(b)(4).The customer returned one spring wire guide (swg), one cvc catheter, and one dilator for analysis.Visual analysis revealed that the dilator was bent near the distal end of the extrusion.The distal tip also appeared deformed and split.Microscopic examination confirmed the damage on the dilator.Stress marks and folds were also observed, which is consistent with damage due to undue force being applied during insertion.The returned swg was also kinked.The dilator total length measured 5.433", which is within the specification limits of 5.25"-5.75" per the dilator.The dilator outer diameter measured.1571", which is within the specification limits of.156"-.160" per the dilator graphic.The dilator inner diameter measured.055", which is within the specification limits of.051"-.061" per the dilator graphic.A lab inventory guide wire with the same diameter as the returned guide wire was passed through the defective dilator.Minor resistance was observed due to the defective tip; however, the guide wire was able to pass completely through the dilator.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit provides the proper technique for inserting the tissue dilator.The ifu states, "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide".The ifu then states, "use tissue dilator to enlarge site as required".The report of a defective dilator body was confirmed through complaint investigation.Visual analysis revealed that the dilator was bent near the distal end of the extrusion.Microscopic examination also revealed that the dilator tip was damaged and split.The dilator met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9162958
• MDR Text Key: 178372930
• Report Number: 3006425876-2019-00753
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 09/18/2019

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: Health Professional
• Device Expiration Date: 11/05/2020
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F18L2487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 04/03/2020
• Supplement Dates FDA Received: 11/05/2019; 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR