MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN030863

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 03/27/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "involved a (b)(6) year-old patient hospitalized for treatment of an acute coronary syndrome.The catheter was inserted on (b)(6) 2021 in the femoral site.The patient was found with his cvc detached and on the ground.The 2 stitches were still in place but the juncture hub was cracked." it was reported the plastic wings were cracked.The patient did not have cordarone infusion for over two hours, but there was no patient injury or complication.The catheter was not replaced, the patient received treatment through a peripheral vein.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cvc for analysis.Visual analysis of the returned catheter revealed that it was damaged at the suture wings of the juncture hub.The separation points were rough and jagged which is consistent with undue force being applied to the line.Based on the customer report, it appears that the sutures were initially secured onto the catheter suture wings but detached when the damage to the suture wings occurred.Evidence of use in the form of biological material was observed in the returned catheter.The length of the catheter juncture hub from one side of the suture wings to the distal end of the juncture hub measured 19mm, which is within the specification limits of 18mm-20 mm per the catheter graphic.Functional inspection could not be performed due to the damage on suture wings of the juncture hub.Manufacturing was consulted and they indicated that the "catheter is standardly inspected before use , meaning this failure happened during/after usage." a device history record review was performed with no relevant findings.The instructions-for-use provided with this kit instructs the user, "use triangular juncture hub with side wings as primary suture site." the customer complaint was confirmed by complaint investigation of the returned sample.Visual examination of the catheter revealed both of the suture wings on the juncture hub were cracked.The separation points were rough and jagged which is consistent with undue force being applied to the line.A device history record review was performed with no relevant findings.Manufacturing was consulted and they indicated that the catheter is standardly inspected before use, meaning this failure happened during/after usage.Based on the sample received and the fact that the incident occurred during use, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend complaints of this nature.

Event Description

The complaint is reported as: "involved a 76-year-old patient hospitalized for treatment of an acute coronary syndrome.The catheter was inserted on 27 march 2021 in the femoral site.The patient was found with his cvc detached and on the ground.The 2 stitches were still in place but the juncture hub was cracked." it was reported the plastic wings were cracked.The patient did not have cordarone infusion for over two hours, but there was no patient injury or complication.The catheter was not replaced, the patient received treatment through a peripheral vein.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11724206
• MDR Text Key: 247262891
• Report Number: 3006425876-2021-00344
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902000559
• UDI-Public: 10801902000559
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 04/06/2021

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: No Information
• Device Model Number: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F20K0494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORDARONE; CORDARONE; CORDARONE
• Patient Age: 76 YR