MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI SET: 6 FR; INTRODUCER, CATHETER

Catalog Number SI-09600

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "during cardiac pacing procedure, the tissue dilator is failed to lock into position when fit into the sheath thus required to change another sheath introducer set." no patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one sheath/dilator assembly and lidstock for analysis.Signs-of-use in the form of biological material were observed on the sheath tip.The dilator was returned inserted through the proximal end of the sheath, which indicates that the customer handled the sample.After failing functional testing (see below), it was observed that the distal base of the dilator hub appeared to be defective.The defect appears consistent with damage due to a molding issue during manufacturing.The hemostasis valve opening inner diameter measured 0.155" which is within the specifications of 0.154-0.156" per the hemostasis valve cap drawing.The dilator hub distal base measured 0.15520" which is not within the specification limits of 0.156-0.158" per the dilator graphic.The dilator/sheath assembly was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "insert entire length of dilator through hemostasis valve into sheath pressing hub of dilator firmly into hub of hemostasis valve/side port assembly." the returned dilator was inserted into the returned sheath hub.The dilator did not snap into place and could be easily removed from the sheath hub.A device history record review was performed, and no relevant findings were found.The reported complaint that the dilator does not lock into the sheath was confirmed through testing of the returned sample.The returned components were functionally tested, and the dilator would not lock into the sheath.Dimensional examination revealed that the dilator hub was out of specification.This prevented the hub from locking into the sheath as intended.Based on this investigation, the probable cause of this complaint is manufacturing related.A non-conformance request was initiated to further investigate this complaint issue.

Event Description

The complaint is reported as: "during cardiac pacing procedure, the tissue dilator is failed to lock into position when fit into the sheath thus required to change another sheath introducer set." no patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PSI SET: 6 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12484900
• MDR Text Key: 271898208
• Report Number: 9680794-2021-00491
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SI-09600
• Device Lot Number: 14F20K0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1