MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number CV-17702-E

Device Problem Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges the guidewire folded when removed.

Manufacturer Narrative

(b)(4).The customer returned a 2-lumen 7 fr x 20 cm cvc catheter and a spring-wire guide (swg) for evaluation.The catheter appeared used; however, no defects or anomalies were observed.Visual examination of the swg revealed the guide wire core wire is separated in the middle of the swg body and the coil wire is unraveled in the same location.There is also a kink in the swg body.Microscopic examination of the swg confirmed the inner core wire is fractured in the middle of the swg body and the kink in the swg body.Both distal and proximal ends of the protruding separated core wire appeared curved and cylindrical in shape.This appearance is consistent with a swg that has been withdrawn against a needle bevel.The distal and proximal ends of the swg appear undamaged, and both welds are full intact and spherical.The swg kink was located approximately 261 mm from the proximal end of the swg.The distal end of the separated core wire measured 305 mm and the proximal end measured 296 mm (totaling 601 mm).The total length is within specification; therefore, no pieces appear to be missing.The outside diameter (od) of the guide wire measured 0.851 mm, which met specification.A swg with an od of 0.851 mm from lab inventory passed through the returned catheter from the hub to the tip without restriction.This indicates that a swg with an od of 0.798 mm would be able to pass through the catheter as well.A manual tug test confirmed the distal and proximal welds are intact.A device history review was performed and no relevant manufacturing findings were identified.The product's instructions-for-use states that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement the catheter should be withdrawn 2-3 cm relative to the spring-wire guide and another attempt should be made to remove it.If resistance is felt again the spring-wire guide and catheter should be removed simultaneously.Applying undue force may cause the spring- wire guide to break.The ifu also cautions that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The reported complaint that the guide wire unraveled while using the catheter was confirmed through visual and functional examination of the returned sample.The swg core wire was separated in the middle of the swg body and the coil wire was unraveled in the same location.A kink was also found in the swg body.A swg with an od of 0.851 mm from lab inventory passed through the returned catheter from the hub to the tip without restriction.This indicates that a swg with and od of 0.798 mm would be able to pass through the catheter as well.In addition, no manufacturing defects were found during this investigation.Arrow guide wires of this size (0.035") are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, it was determined that operational context caused or contributed to this issue.

Event Description

The customer alleges the guide wire folded when removed.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7080388
• MDR Text Key: 93753978
• Report Number: 9680794-2017-00271
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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: 08/31/2021
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 14F16J0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR