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

Catalog Number SI-09903-E

Device Problems Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

"it was reported that the user felt a resistance when advancing a swan-ganz catheter of other company into the cath-gard, and the balloon of the catheter got ruptured.Therefore, it was removed and replaced with a new kit." no patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

"it was reported that the user felt a resistance when advancing a swan-ganz catheter of other company into the cath-gard, and the balloon of the catheter got ruptured.Therefore, it was removed and replaced with a new kit." no patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one open psi kit containing a cath-gard as well as an 8fr swan-ganz catheter for evaluation.Visual inspection of the cath-gard did not reveal any defects or anomalies.Visual inspection of the returned swan-ganz confirmed the balloon portion had been torn and separated.The inner diameter of the proximal housing measured 0.123", which is within specifications of 0.120-0.130" per the housing graphic.The inner diameter of the distal housing measured 0.126", which is within specifications of 0.120-0.130" per the housing graphic.The cath-gard was functionally tested with the returned 8fr swan-ganz catheter per the instructions for use (ifu).The ifu provided with this kit states, "insert tip of desired catheter through proximal end of catheter contamination shield.Advance catheter through tubing and hub at other end.Slide entire catheter contamination shield to proximal end of catheter." the 8fr swan-ganz catheter was able to advance through the cath-gard with no issues.When the housings of the cath-gard were turned to the locking position, the swan-ganz was unable to slide within the cath-gard.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not inflate balloon prior to insertion through catheter contamination shield to minimize the risk of balloon damage." the complaint of a cath-gard damaging the inserted catheter was confirmed by a complaint investigation on the returned sample.The returned swan-ganz catheter was found to have a torn and separated balloon.The returned cath-gard passed all relevant dimensional and functional testing.A device history record review was performed, and no relevant findings were identified.Based on the sample returned, no defects or anomalies were detected on the cath-gard so the root cause cannot be determined at this time.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

"it was reported that the user felt a resistance when advancing a swan-ganz catheter of other company into the cath-gard, and the balloon of the catheter got ruptured.Therefore, it was removed and replaced with a new kit." no patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PSI SET: 9 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12970807
• MDR Text Key: 283091370
• Report Number: 9680794-2021-00643
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SI-09903-E
• Device Lot Number: 14F21A0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1