MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 22GA X 8CM; CATHETER, PERCUTANEOUS

Model Number IPN055218

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint was reported as: "swg has threaded itself and was almost impossible to remove.The wire had to be removed from the artery and a new one had to be placed.The patient was not harmed.The goods complained about were disposed of by the customer.The complete batch was sent back by the customer." additional information received reported the spring wire guide had unraveled.The patient's condition was reported as "fine".

Event Description

The complaint was reported as: "swg has threaded itself and was almost impossible to remove.The wire had to be removed from the artery and a new one had to be placed.The patient was not harmed.The goods complained about were disposed of by the customer.The complete batch was sent back by the customer." additional information received reported the spring wire guide had unraveled.The patient's condition was reported as "fine".

Manufacturer Narrative

(b)(4).Visual inspection could not be performed on the actual complaint sample as it was not returned for analysis.Instead, the customer returned three unopened representative arterial catheter sets from lot # 71f20d1528 for evaluation.No defects or anomalies were observed on the guide wires from the representative kits.The guide wire outer diameter for each representative sample measured 0.520mm, 0.515mm and 0.515mm, respectively which are within the specification of 0.508-0.533 mm per guide wire product drawing.The guide wire length for each representative sample measured 350 mm which is within the specification of 345-355 mm per guide wire product drawing.The representative samples passed all relevant dimensional requirements.The guide wire from each representative sample was advanced through the corresponding catheter and introducer needle with minimal resistance.All components functioned as expected.A manual tug test was performed and it was confirmed that the distal and proximal welds for each were intact.A device history record review was performed with no relevant findings.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu includes the following warnings , cautions and instructions for the user: "do not cut spring-wire guide." "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing of spring-wire guide." "precaution: use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter simultaneously.Use of excessive force may damage catheter or spring-wire guide." complaint verification testing could not be performed as the actual complaint sample was not returned for analysis.Three unopened representative arterial catheter sets from lot # 71f20d1528 were returned and met all relevant visual, dimensional, and functional requirements.A device history record review was performed and no relevant findings were identified.Without the actual complaint 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.

• Brand Name: ARROW ARTERIAL CATH SET: 22GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10560011
• MDR Text Key: 207723715
• Report Number: 3006425876-2020-00808
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• 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: 09/02/2020

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 Model Number: IPN055218
• Device Catalogue Number: SAC-00822
• Device Lot Number: 71F20D1528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.