MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR; INTRODUCER CATHETER

Catalog Number AJ-09903

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that, when the user inserted a swan-ganz catheter of edwards to the sheath, the balloon of the catheter got ruptured.Therefore, both sheath and catheter were removed and replaced with new ones.No patient injury or complication reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one, opened psi kit for analysis.The sheath/dilator will be analyzed as part of this complaint investigation.No definite signs-of-use were observed.In addition to the sample being returned with the protective tubing over the sheath, the dilator was also inserted through the distal end.The swan-ganz catheter was not returned for analysis.Visual examination of the psi did not reveal any defects or anomalies.The total length of the sheath body measured to be 3 7/16", which is within the specification limits of 3 1/4"-3 1/2" per the sheath graphic.The inner diameter of the sheath at the proximal end measured.123", which is within the specification limits of.118"-.128" per the sheath graphic.The sheath inner diameter at the distal end measured.118", which is within the specification limits of.117"-.118" per the sheath graphic.A lab inventory 7.5fr swan-ganz catheter was inserted through the sheath body.The catheter was able to be advanced and retracted with little to no difficulty.A device history record review was performed with no relevant findings.The customer report of catheter/sheath resistance could not be confirmed by complaint investigation of the returned sample.The returned psi passed all relevant visual, dimensional, and functional testing.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, no problem was found with the teleflex device.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that, when the user inserted a swan-ganz catheter of edwards to the sheath, the balloon of the catheter got ruptured.Therefore, both sheath and catheter were removed and replaced with new ones.No patient injury or complication reported.The patient's condition is reported as fine.

• Brand Name: ARROW PSI KIT: 9 FR
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11087729
• MDR Text Key: 224299097
• Report Number: 9680794-2020-00517
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: AJ-09903
• Device Lot Number: 13F19H0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EDWARDS SWAN-GANZ CATHETER.; EDWARDS SWAN-GANZ CATHETER.