MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Catalog Number CS-12402

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the catheter/guide wire is dysfunctional (bent) during use.

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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The customer reports that the catheter/guide wire is dysfunctional (bent) during use.

Manufacturer Narrative

(b)(4).The customer returned one guide wire and a lidstock for analysis.No definite signs-of-use were observed.Visual analysis revealed that the guide wire had unraveled towards the proximal end.This resulted in the j-bend to be severely deformed.Microscopic examination revealed that the proximal weld had separated from both the core wire and the coil wire.Examination of point of separation revealed that the coil wire contained minor scratch marks, which indicates that user error likely caused or contributed to this event.The weld was not returned for analysis.The distal weld appeared to be spherical and full.The guide wire length from the distal weld to the point of separation on the core wire measured 10.91", which indicated that at least 6.78" of the guide wire had separated and was not returned for analysis (per the guide wire graphic).The guide wire outer diameter measured.017", which is within the specification limits of.017"-.018" per the guide wire graphic.A manual tug test confirmed that the distal weld was secure and intact.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu provided with the kit informs the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report that the guide wire was separated during use was confirmed through examination of the returned sample.The guide wire was observed to be separated at the proximal end with the proximal weld missing.Dimensional analysis revealed that at least 6.78" of the guide wire had separated and was not returned for analysis.A device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2 pound force.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 the condition of the guide wire and the report that the damage was observed during treatment, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the catheter/guide wire is dysfunctional (bent) during use.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 5 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10043798
• MDR Text Key: 190529982
• Report Number: 9680794-2020-00225
• 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,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• 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-12402
• Device Lot Number: 14F18M0285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 DA
• Patient Weight: 3