MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Catalog Number CP-07611

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the dilator and sheath did not fit well.The md used another new product and finished the procedure.

Event Description

The customer reports that the dilator and sheath did not fit well.The md used another new product and finished the procedure.

Manufacturer Narrative

Qn#(b)(4).The customer returned a sheath/dilator assembly with dilator inserted for evaluation.No anomalies or defects were found during visual inspection of either component.The hemostasis valve opening inner diameter measured 0.146", which is within the specifications of 0.144"-0.147" per hemostasis valve cap drawing.The dilator hub distal base measured 0.14945", which is within the specifications of 0.149"-0.151" per dilator drawing.The outer diameter of the sheath ext.Assembly measured 0.113", which is within specifications of 0.111"-0.115" per sheath ext.Assembly graphic.The inner diameter of the sheath tip measured 0.084", which is within specification of 0.083"-0.085" per sheath ext.Assembly graphic.To functionally test the two components, the returned dilator was inserted into the returned sheath hub.The dilator snapped into place and was secure within the sheath hub.No fault found.The returned dilator was able to advance and retract through the returned sheath with minimal resistance.A device history record review was performed on the sheath and dilator with no relevant manufacturing findings identified.The instructions for use (ifu) provided with this kit instructs the user, "ensure dilator hub fully snaps into sheath cap." the reported complaint that the dilator does not lock into the sheath could not be confirmed through testing of the returned sample.The returned components were functionally tested and the dilator locked into the sheath with no issues.The device passed all functional and dimensional testing.Device history records were reviewed with no evidence to suggest a manufacturing related cause.Based on the sample returned no problem was found on the sample.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10088384
• MDR Text Key: 193055486
• Report Number: 9680794-2020-00253
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CP-07611
• Device Lot Number: 14F15E0408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1