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 09/20/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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." the issue was detected prior to insertion.The device was replaced, and procedure completed.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one sheath/dilator assembly for analysis.Signs-of-use in the form of what appears to be traces of biological material was 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, 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 0.156", which is within the specifications of 0.154-0.156" per the hemostasis valve cap drawing.The dilator hub distal base measured.153", which is not within the specification limits of.156"-.158" per the dilator graphic.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.Non-conformances were initiated on september 2019 to address the same failure mode.This involved all us34 lots manufactured prior to november 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.Visual and microscopic examination revealed that the dilator hub had slightly lost its shape.This prevented the hub from locking into the sheath as intended.To go with this, the dilator hub did not meet the specification limits defined in the graphic.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.Teleflex will continue to monitor and trend for reports of this nature.

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." the issue was detected prior to insertion.The device was replaced and procedure completed.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: 10677399
• MDR Text Key: 211514593
• Report Number: 9680794-2020-00411
• 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: 09/24/2020

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: 07/31/2024
• Device Catalogue Number: SI-09600
• Device Lot Number: 14F19G0380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.