MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8"; CATHETER, PERCUTANEOUS

Catalog Number SA-17702-J

Device Problems Partial Blockage (1065); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.

Event Description

The customer reports after placement of the catheter, medical agent couldn't be injected to the patient from one of the lumens as it was blocked.As a result of this issue, the other lumen was used instead of the blocked lumen.Therefore, the inserted catheter was used as it is.Flashing test was successfully completed prior to use.

Manufacturer Narrative

(b)(4).The customer returned a single 2-lumen cvc catheter for evaluation.The catheter showed evidence of use in the form of dried blood within the proximal extension line.Two sutures were tied to separate locations on the catheter body.Another suture was tied to the catheter juncture hub suture wing.Note: the suture closer to the distal tip separated during decontamination of the sample.Visual examination revealed the suture closest to the juncture hub was wrapped around the entire catheter body.Dried blood could be observed within the catheter body, in the extension lines and in the skive marks.Microscopic examination revealed that the suture closest to the juncture hub was pinching the material of the catheter body.The remaining suture on the catheter body was located 34 mm from the juncture hub.The catheter body length and outer diameter were measured and were found to be within specification.Resistance was met when attempting to flush both of the extension lines with water.The suture on the catheter body was removed and another attempt was made to flush the extension lines.Initially, resistance was met but dried blood was observed exiting the catheter through the skive holes.Once the lines had been cleared of the dried blood both were able to be flushed with minimal resistance.It is believed the combination of the suture and the dried blood caused the catheter blockage.A device history record review was performed on the catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit cautions the user to not suture directly to the outside diameter of the catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow.The ifu also notes to prepare the catheter for insertion by flushing each lumen and clamping or attaching the injection caps to the appropriate pigtails.If the catheter was blocked prior to use, it would have been identified at this step.The ifu was not followed by the user since the catheter was returned with sutures directly on the catheter body.Therefore, an in-service request was made to the sales representative for this customer.The customer report that medical agent could not be injected due to one of the lumens being blocked was confirmed through evaluation of the returned catheter.The catheter was returned with significant dried blood within the catheter and two sutures tied around the catheter body.No blockages were observed after the sutures were removed and catheter flushed of dried blood.Therefore it is believed the sutures and dried blood caused the blockage in use.The ifu for this product states to not suture directly to the outside diameter of the catheter to minimize the risk of impeding catheter flow.Therefore, user error caused or contributed to this event.An in-service request was initiated to follow up with the customer on proper use according to the ifu.

Event Description

The customer reports after placement of the catheter, medical agent couldn't be injected to the patient from one of the lumens as it was blocked.As a result of this issue, the other lumen was used instead of the blocked lumen.Therefore, the inserted catheter was used as it is.Flashing test was successfully completed prior to use.

• Brand Name: ARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8"
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7019524
• MDR Text Key: 92051139
• Report Number: 3006425876-2017-00499
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

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 Expiration Date: 02/28/2019
• Device Catalogue Number: SA-17702-J
• Device Lot Number: 71F17C0557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• 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