MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Model Number IPN000072

Device Problem Difficult to Advance (2920)

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

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the guide wire gets stuck at the tip of the catheter.It happened with two catheters.Third one worked properly".No patient harm, injury, or consequence reported.Patient condition reported as "fine".Additional information received stated that the two catheters were used on the same patient, part and lot number were the same for both devices.No issues with the third catheter.Associated to mdr 3010532612-2022-00310.

Manufacturer Narrative

(b)(4).The reported complaint that the "guide wire gets stuck at the tip of the catheter" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.

Event Description

It was reported that "the guide wire gets stuck at the tip of the catheter.It happened with two catheters.Third one worked properly".No patient harm, injury, or consequence reported.Patient condition reported as "fine".Additional information received stated that the two catheters were used on the same patient, part and lot number were the same for both devices.No issues with the third catheter.Associated to mdr 3010532612-2022-00310.

Manufacturer Narrative

(b)(4).The reported lot number matches the lot number on the returned original packaging pouch.Returned for investigation was a 6fr.Wedge 110cm catheter with its original packaging pouch.The sample was returned in a cardboard box and was in a sealed bio-hazard bag.The sample was loosely packed within the original packaging pouch.Upon return, the supplied 1.0cc control stroke syringe was connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 1.0cc.Upon microscopic inspection, a wrinkle was noted on the balloon surface.No condensation was noted in the inflation lumen extension line.No contrast media was noted within the injection lumen extension line.No blood was noted on the interior or the exterior surfaces of the returned sample.Upon further inspection, no blockage or abnormalities were noted to the distal tip of the catheter.No kink, bend or flattened surface was noted on the returned catheter extrusion/body.No other damage or abnormalities were noted to the returned sample.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 5mm.The other side measured approximately 5mm.The balloon did meet specifications per manufacturing graphic of radius ratio less than or equal to 1.5.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per internal manufacturing specification.No pull away was noted after the tug test.The balloon was placed in water and air was injected into the inflation lumen again.No leak was noted.A lab inventory 0.025in guidewire was back loaded through the distal tip of the catheter.No resistance was noted; the guidewire was able to advance through without any difficulty.No blood or debris was noted.The guidewire was front loaded through the injection extension luer.No resistance was noted; the guidewire was able to advance through without any difficulty.No blood or debris was noted.The injection lumen was aspirated and flushed.No blood or debris was noted.The reported complaint that the "guide wire gets stuck at the tip of the catheter" is not confirmed.A device history record review was performed, and no relevant findings were identified.The root cause of the complaint is undetermined.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "the guide wire gets stuck at the tip of the catheter.It happened with two catheters.Third one worked properly".No patient harm, injury, or consequence reported.Patient condition reported as "fine".Additional information received stated that the two catheters were used on the same patient, part and lot number were the same for both devices.No issues with the third catheter.Associated to mdr 3010532612-2022-00310.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15197903
• MDR Text Key: 304834135
• Report Number: 3010532612-2022-00309
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K892530
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2023
• Device Model Number: IPN000072
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22B0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Age: 70 YR
• Patient Sex: Female