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 Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

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 injury or harm reported.The condition of the patient is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The customer returned a sheath extension assembly, spring wire guide, and lidstock for evaluation.No anomalies or defects were found during visual inspection of either component.The hemostasis valve opening inner diameter measured 0.155", which is within the specifications of 0.154-0.156" per hemostasis valve cap drawing.The dilator hub distal base measured 0.1681", which is not within the specifications of 0.169"-0.171" per dilator drawing.To functionally test the two components, 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 with one relevant finding.A non-conformance was initiated for batch 34c18b0019 to address the same failure mode on lots manufactured before nov 07, 2019.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 testing was performed and determined that the cause of the issue was the dilator hub outer diameter being undersized.Based on this investigation, the probable cause of this complaint is manufacturing related.Non-conformance request has been 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 injury or harm reported.The condition of the patient 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: 10562583
• MDR Text Key: 207817914
• Report Number: 9680794-2020-00380
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: SI-09600
• Device Lot Number: 14F18G0314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.