MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number EU-25853-CVT

Device Problems Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preliminary evaluation of the returned device indicates swg/catheter resistance - kinked.The device product is not intended for sale in the us.Similar device sold in the us.A device history record review was performed on the catheter and guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product ((b)(4)) describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.

Event Description

The customer reports it was not possible to advance the cvc over the swg (spring wire guide); a resistance was noted.

Manufacturer Narrative

(b)(4).The customer returned a single 3-lumen catheter and the guide wire for evaluation.Visual examination of the catheter did not reveal any defects or anomalies.Visual examination of the guide wire revealed a slight bend/kink towards the proximal end of the body.Both of the welds were full and spherical.The catheter body length measured 215 mm which is within specification.The kink in the guide wire was located 161 mm from the proximal tip.The length and outer diameter of the guide wire were measured and were found to be within specification.The returned guide wire was advanced through the proximal tip of the returned guide wire in order to functionally test the components.The guide wire was able to advance through the catheter body but could not advance through the catheter juncture hub.When the guide wire was advanced from the distal extension lines it was able to fully pass through the catheter and out of the catheter distal tip.All 3 extension lines on the catheter were flushed with water and functioned as expected.No sign of blockage or inter lumen crossover was observed.A device history record review was performed on the catheter and guide wire and no relevant manufacturing issues were identified.The reported complaint of difficulty passing the guide wire through the catheter was confirmed by complaint investigation.The returned guide wire was unable to pass through the juncture hub of the returned catheter.A device history record review was performed with no relevant findings.Based on the sample received, manufacturing caused or contributed to this event.A capa has been initiated to further investigate this issue.

Event Description

The customer reports it was not possible to advance the cvc over the swg (spring wire guide); a resistance was noted.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7610652
• MDR Text Key: 111440343
• Report Number: 3006425876-2018-00414
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: EU-25853-CVT
• Device Lot Number: 71F18B0433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1